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Trial record 78 of 108 for:    CALCIUM CATION

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

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ClinicalTrials.gov Identifier: NCT01825785
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Postmenopausal
Osteopenia
Interventions Drug: Romosozumab
Drug: Placebo
Enrollment 48
Recruitment Details This study was conducted at 4 centers in the United States (US) from 14 November 2007 to 2 December 2008.
Pre-assignment Details Participants were enrolled into 1 of 6 cohorts. In each of cohorts 1 to 4, healthy postmenopausal women were randomized in a 3:1 ratio to receive romosozumab or placebo; In each of cohorts 5 and 6, healthy men were randomized in a 3:1 ratio to receive romosozumab or placebo.
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Period Title: Overall Study
Started 12 6 6 6 6 6 6
Completed 12 6 6 6 4 5 6
Not Completed 0 0 0 0 2 1 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0
Withdrawal by Subject             0             0             0             0             1             1             0
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men Total
Hide Arm/Group Description Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Total of all reporting groups
Overall Number of Baseline Participants 12 6 6 6 6 6 6 48
Hide Baseline Analysis Population Description
All treated participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
59.1  (5.6) 56.8  (7.8) 57.3  (6.6) 62.5  (8.0) 54.3  (7.8) 61.2  (9.0) 59.3  (12.7) 58.7  (8.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
18 to 64 years
11
  91.7%
4
  66.7%
5
  83.3%
4
  66.7%
5
  83.3%
3
  50.0%
4
  66.7%
36
  75.0%
65 to 74 years
1
   8.3%
2
  33.3%
1
  16.7%
1
  16.7%
1
  16.7%
3
  50.0%
1
  16.7%
10
  20.8%
≥ 75 years
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
  16.7%
2
   4.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
Female
8
  66.7%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
0
   0.0%
0
   0.0%
32
  66.7%
Male
4
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
 100.0%
6
 100.0%
16
  33.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 48 participants
White
8
  66.7%
4
  66.7%
5
  83.3%
3
  50.0%
3
  50.0%
3
  50.0%
3
  50.0%
29
  60.4%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   2.1%
Hispanic or Latino
3
  25.0%
2
  33.3%
1
  16.7%
3
  50.0%
3
  50.0%
3
  50.0%
2
  33.3%
17
  35.4%
American Indian or Alaska Native
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.

Relatedness to investigational product was assessed by the investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?'

Time Frame 169 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
10
  83.3%
6
 100.0%
6
 100.0%
6
 100.0%
5
  83.3%
5
  83.3%
5
  83.3%
Serious adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
Treatment-related adverse events
6
  50.0%
1
  16.7%
1
  16.7%
4
  66.7%
3
  50.0%
3
  50.0%
2
  33.3%
Treatment-related serious adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Discontinuation due to adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
Death on study
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants Who Developed Antibodies to Romosozumab
Hide Description

All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing.

Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline.

Time Frame Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Binding antibodies
0
   0.0%
2
  33.3%
2
  33.3%
2
  33.3%
3
  50.0%
1
  16.7%
3
  50.0%
Neutralizing antibodies
0
   0.0%
1
  16.7%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
3.Secondary Outcome
Title Time to Maximum Observed Concentration (Tmax) of Romosozumab
Hide Description Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.
Time Frame Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Arm/Group Title Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 5 6 6 5 5 6
Median (Full Range)
Unit of Measure: days
First dose
3.0
(2.0 to 5.0)
3.0
(3.0 to 5.0)
4.5
(3.0 to 7.0)
3.0
(3.0 to 5.0)
3.0
(3.0 to 5.0)
5.0
(3.0 to 5.0)
Last dose
3.0
(3.0 to 5.0)
3.0
(1.0 to 4.0)
3.5
(3.0 to 5.0)
5.0
(2.0 to 7.0)
3.0
(3.0 to 5.0)
3.0
(3.0 to 5.0)
4.Secondary Outcome
Title Maximum Observed Concentration (Cmax) of Romosozumab
Hide Description [Not Specified]
Time Frame Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Arm/Group Title Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 5 6 6 5 5 6
Mean (Standard Deviation)
Unit of Measure: μg/mL
First dose 6.80  (1.86) 15.7  (4.6) 14.8  (6.0) 24.5  (6.8) 8.06  (1.57) 27.7  (4.2)
Last dose 14.2  (4.3) 16.7  (3.3) 27.8  (8.4) 29.5  (8.7) 13.4  (4.4) 37.1  (8.1)
5.Secondary Outcome
Title Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab
Hide Description Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)
Time Frame Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Arm/Group Title Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 5 6 6 5 5 6
Mean (Standard Deviation)
Unit of Measure: μg*day/mL
First dose 65.5  (15.6) 202  (48) 152  (63) 340  (73) 71.3  (11.8) 434  (81)
Last dose 141  (41) 231  (58) 321  (97) 462  (97) 136  (42) 555  (181)
6.Secondary Outcome
Title Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab
Hide Description [Not Specified]
Time Frame Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Arm/Group Title Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 5 6 6 5 5 6
Mean (Standard Deviation)
Unit of Measure: days
7.02  (3.52) 6.51  (1.37) 9.32  (1.88) 6.84  (1.79) 6.77  (1.92) 6.07  (1.50)
7.Secondary Outcome
Title Accumulation Ratio (AR) for Romosozumab
Hide Description The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.
Time Frame Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.
Arm/Group Title Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 5 6 6 4 5 6
Mean (Standard Deviation)
Unit of Measure: ratio
2.15  (0.45) 1.17  (0.26) 2.35  (0.90) 1.35  (0.19) 1.90  (0.49) 1.26  (0.23)
8.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density of the Total Spine
Hide Description Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.
Time Frame Baseline and days 29, 85, 127, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 29 Number Analyzed 11 participants 5 participants 5 participants 6 participants 5 participants 5 participants 6 participants
-0.046  (0.778) 2.161  (0.177) 0.541  (1.296) -0.495  (0.930) -0.257  (0.623) 2.662  (0.804) -0.660  (1.240)
Day 85 Number Analyzed 11 participants 5 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-0.843  (0.829) 3.579  (1.942) 3.881  (1.437) 3.853  (0.543) 3.146  (2.027) 3.135  (1.085) 4.157  (0.714)
Day 127 Number Analyzed 10 participants 5 participants 5 participants 6 participants 4 participants 5 participants 6 participants
0.177  (0.907) 4.313  (3.057) 7.219  (1.243) 6.350  (0.732) 5.566  (2.142) 4.462  (1.787) 5.599  (0.756)
Day 169 Number Analyzed 11 participants 5 participants 5 participants 6 participants 6 participants 5 participants 6 participants
-0.559  (1.013) 4.769  (1.916) 4.835  (1.116) 5.250  (1.630) 4.980  (2.111) 5.187  (0.825) 6.560  (1.293)
9.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density at the Total Hip
Hide Description Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time Frame Baseline and days 29, 85, 127, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-0.552  (0.347) 0.528  (0.617) -0.768  (0.334) 0.112  (0.940) -0.318  (1.182) 1.244  (1.368) -0.902  (0.408)
Day 85 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-0.613  (0.529) 1.066  (0.938) 0.639  (0.608) 2.116  (0.477) 2.088  (0.550) 1.134  (0.797) 0.731  (0.621)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-0.793  (0.623) 0.702  (1.180) 0.621  (0.940) 2.855  (0.778) 3.996  (1.109) 2.111  (0.486) 1.455  (0.669)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.511  (0.380) 1.423  (1.047) 0.894  (1.013) 3.176  (1.105) 2.094  (0.751) 1.007  (0.422) 0.370  (0.629)
10.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density at the Femoral Hip
Hide Description Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time Frame Baseline and days 29, 85, 127, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-0.394  (0.573) 0.300  (0.813) -2.172  (1.331) -0.811  (1.596) -0.473  (1.987) 0.471  (1.919) -0.597  (0.839)
Day 85 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-1.175  (1.042) 1.360  (1.031) 0.578  (1.285) -0.123  (1.001) 0.270  (1.176) 1.301  (0.681) 1.956  (1.493)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-2.301  (0.745) 1.284  (1.255) -1.005  (2.609) 1.471  (1.228) 1.332  (2.488) 1.861  (1.208) 0.091  (1.110)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.447  (0.673) 0.801  (1.208) -0.672  (1.783) 0.510  (1.103) 2.197  (1.674) 1.665  (1.582) 0.116  (2.003)
11.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius
Hide Description Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time Frame Baseline and days 29, 85, 127, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
1.676  (0.897) -0.220  (0.998) -0.900  (0.733) -2.052  (1.295) -2.968  (0.930) -0.435  (1.078) -1.185  (1.101)
Day 85 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.609  (0.943) -0.082  (1.012) -2.740  (0.770) 0.803  (1.411) -4.125  (0.421) -2.504  (1.777) -0.993  (1.478)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.835  (0.988) 0.680  (1.345) -1.037  (0.668) 0.633  (1.450) -4.739  (0.642) -1.756  (1.158) -2.263  (1.227)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.191  (0.753) 0.522  (1.835) 0.240  (1.068) -0.028  (1.943) -3.647  (0.924) -1.836  (1.145) -1.449  (1.106)
12.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Hide Description Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time Frame Baseline and days 29, 85, 127, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
0.135  (0.529) -0.552  (1.134) -0.014  (0.591) -0.020  (0.944) -0.438  (1.054) 0.757  (0.698) 0.021  (0.479)
Day 85 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.329  (0.604) -0.063  (1.269) -0.754  (0.533) 0.448  (0.549) -3.621  (1.424) -0.306  (0.510) 0.160  (0.296)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.236  (0.563) -1.134  (1.388) 0.493  (0.792) -0.739  (0.595) -3.326  (1.895) -0.914  (0.338) -1.019  (0.647)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
0.417  (0.768) -1.102  (1.834) -0.928  (0.717) -0.234  (1.126) -2.632  (1.466) -0.378  (0.818) -0.211  (0.619)
13.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density of the Whole Body
Hide Description Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.
Time Frame Baseline and days 29, 85, 127, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-0.391  (0.347) 0.493  (0.580) -1.122  (0.885) -0.532  (0.188) 0.521  (0.567) -0.058  (0.387) -0.611  (0.344)
Day 85 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.103  (0.391) 0.259  (0.642) -0.324  (0.827) 1.359  (0.276) -0.151  (0.614) 0.459  (0.271) 0.243  (0.447)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.000  (0.371) -1.068  (0.357) -0.486  (0.938) 1.442  (0.862) 0.513  (0.600) 1.919  (0.839) 0.012  (0.562)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.352  (0.320) 0.180  (1.143) -0.294  (0.597) 1.284  (0.637) 0.801  (0.523) 1.285  (0.264) 0.218  (0.819)
14.Secondary Outcome
Title Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)
Hide Description [Not Specified]
Time Frame Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 2 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-4.55  (3.83) 5.90  (4.97) 4.37  (3.98) 1.18  (4.35) -0.71  (3.94) 8.46  (6.50) -0.64  (13.43)
Day 4 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
0.81  (3.92) 14.72  (5.61) 16.32  (6.77) 7.99  (10.60) 9.53  (9.47) 15.32  (7.40) 10.72  (15.27)
Day 6 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-5.99  (4.33) 46.69  (7.59) 32.85  (7.41) 23.19  (10.40) 32.18  (4.75) 27.78  (7.72) 33.83  (19.09)
Day 8 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-1.65  (5.47) 45.25  (8.02) 37.14  (11.60) 42.17  (3.90) 69.31  (5.50) 47.44  (12.82) 70.63  (24.65)
Day 15 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.87  (6.06) 58.03  (11.52) 66.12  (14.63) 76.66  (21.28) 103.66  (7.37) 58.81  (12.45) 123.92  (39.13)
Day 22 Number Analyzed 12 participants 6 participants 5 participants 6 participants 6 participants 5 participants 6 participants
0.20  (5.41) 82.97  (21.49) 53.76  (19.99) 107.88  (19.52) 117.63  (9.76) 96.08  (13.47) 142.64  (34.70)
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-0.36  (5.54) 81.45  (20.35) 26.35  (10.41) 118.17  (17.03) 74.50  (16.33) 88.21  (11.96) 115.09  (26.83)
Day 36 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
5.42  (5.56) 78.03  (21.98) 59.50  (21.56) 140.47  (17.70) 103.87  (22.54) 105.96  (14.87) 147.40  (32.52)
Day 43 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
2.97  (5.73) 69.94  (20.47) 62.16  (23.95) 93.15  (20.34) 129.43  (21.06) 98.49  (17.18) 139.62  (31.52)
Day 50 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-12.20  (5.65) 73.72  (23.57) 128.64  (16.55) 86.45  (14.88)
Day 57 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
1.74  (5.20) 51.66  (20.71) 3.28  (10.72) 95.15  (21.45) 77.00  (20.31) 76.98  (12.12) 74.16  (19.64)
Day 58 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
12.47  (6.76) -7.77  (9.58) 54.04  (16.51) 82.95  (20.45)
Day 60 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
3.74  (5.80) 0.47  (5.66) 61.32  (17.08) 85.82  (19.44)
Day 62 Number Analyzed 6 participants 0 participants 5 participants 0 participants 5 participants 0 participants 5 participants
5.62  (2.62) 11.85  (9.79) 64.38  (8.62) 94.88  (12.29)
Day 64 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
12.70  (12.29) 49.88  (14.11) 10.92  (11.34) 65.34  (19.45) 89.15  (12.34) 68.67  (11.96) 113.79  (18.18)
Day 71 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
0.11  (2.87) 51.25  (15.27) 20.01  (13.17) 88.47  (15.08) 64.99  (21.83) 60.58  (14.65) 113.62  (19.09)
Day 72 Number Analyzed 6 participants 6 participants 0 participants 5 participants 0 participants 5 participants 0 participants
-2.97  (4.13) 32.99  (14.43) 71.55  (7.88) 63.76  (15.42)
Day 74 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-11.52  (6.52) 49.16  (15.59) 89.11  (15.49) 71.99  (11.10)
Day 76 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-5.50  (6.48) 45.95  (18.18) 100.22  (18.29) 78.57  (13.74)
Day 78 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
2.61  (5.24) 51.59  (18.64) 1.29  (11.31) 77.58  (19.98) 49.94  (17.55) 75.17  (23.08) 65.32  (13.57)
Day 85 Number Analyzed 12 participants 6 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-2.40  (3.78) 35.64  (11.54) -3.90  (10.10) 79.77  (20.53) 24.94  (9.30) 54.06  (11.05) 44.44  (22.42)
Day 99 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-1.01  (4.04) 3.21  (8.94) -16.47  (8.68) 31.38  (18.42) -5.07  (13.01) 14.97  (8.53) 12.17  (16.53)
Day 113 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
3.39  (5.36) 5.15  (8.34) -14.06  (8.68) -4.43  (9.13) -9.38  (12.06) -0.83  (9.20) -7.13  (11.60)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
5.21  (6.81) -3.26  (6.94) -8.76  (9.73) -9.51  (10.10) -0.76  (17.80) -7.63  (7.01) -5.88  (9.47)
Day 141 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
4.35  (4.72) -5.75  (5.62) -19.84  (7.87) 2.88  (10.84) 22.42  (16.17) -12.85  (12.79) -9.24  (8.87)
Day 155 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
5.71  (4.91) -5.45  (6.57) -19.92  (9.17) -0.73  (8.70) 5.49  (22.07) 1.76  (10.00) -6.88  (9.24)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants
7.58  (7.52) 4.79  (7.31) -16.91  (7.34) 1.42  (6.81) 11.67  (11.51) 5.78  (9.42) -7.07  (10.52)
15.Secondary Outcome
Title Percent Change From Baseline in Osteocalcin
Hide Description [Not Specified]
Time Frame Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 2 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.19  (2.81) 6.61  (2.18) -7.02  (4.56) 4.95  (4.34) -4.09  (6.71) 9.53  (3.94) -4.69  (5.12)
Day 4 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-3.07  (2.54) 1.17  (6.38) -13.51  (1.88) -21.97  (5.50) 6.66  (6.63) 9.13  (17.95) -9.27  (2.61)
Day 6 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-4.74  (2.91) -5.55  (6.37) -14.09  (5.65) -0.71  (6.79) 11.34  (6.43) 16.14  (13.24) -2.00  (3.09)
Day 8 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-3.68  (3.16) -7.13  (3.83) -4.14  (6.29) 22.82  (5.24) 41.85  (29.46) 17.92  (8.35) -2.77  (4.06)
Day 15 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.15  (2.34) 23.55  (10.75) 21.18  (6.94) 33.18  (9.05) 70.19  (15.1) 45.22  (13.53) 24.73  (5.35)
Day 22 Number Analyzed 12 participants 6 participants 5 participants 6 participants 6 participants 5 participants 6 participants
-4.19  (2.06) 29.99  (8.26) 34.90  (16.55) 57.55  (11.24) 84.14  (12.09) 61.18  (19.45) 64.18  (10.17)
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
0.02  (2.67) 49.44  (16.03) 39.52  (11.33) 81.71  (19.20) 90.08  (7.79) 55.58  (10.40) 79.45  (17.12)
Day 36 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
3.54  (2.61) 48.91  (10.93) 35.29  (9.36) 76.70  (12.51) 87.21  (16.45) 35.55  (12.53) 68.03  (8.81)
Day 43 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
1.20  (2.85) 45.46  (12.44) 30.75  (14.39) 77.15  (14.86) 90.14  (17.06) 57.62  (13.39) 82.02  (14.92)
Day 50 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
0.92  (5.00) 48.63  (13.20) 89.23  (18.31) 52.53  (19.49)
Day 57 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
4.07  (2.05) 49.28  (10.45) -0.80  (15.19) 70.82  (16.48) 74.73  (8.81) 69.16  (19.15) 81.16  (16.26)
Day 58 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
7.56  (5.24) 8.12  (11.58) 75.01  (14.15) 75.70  (20.03)
Day 60 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
0.77  (5.59) 3.28  (11.15) 61.68  (9.37) 57.90  (19.58)
Day 62 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 5 participants
14.12  (3.88) 2.04  (9.84) 67.70  (12.26) 47.72  (17.80)
Day 64 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
6.99  (4.49) 27.01  (9.96) 0.57  (10.33) 60.91  (11.91) 70.63  (10.99) 50.40  (22.63) 68.64  (16.90)
Day 71 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
1.87  (3.02) 39.49  (12.97) 27.96  (11.89) 81.01  (20.69) 77.51  (7.93) 51.69  (16.41) 79.70  (19.98)
Day 72 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
5.04  (5.29) 32.17  (9.97) 95.28  (20.14) 63.00  (13.12)
Day 74 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-5.91  (2.36) 31.72  (10.55) 60.58  (13.97) 52.83  (12.14)
Day 76 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 4 participants 0 participants
-4.13  (7.92) 36.41  (9.63) 49.94  (3.93) 60.11  (16.94)
Day 78 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-3.86  (3.35) 29.10  (8.42) 12.60  (11.10) 74.99  (13.37) 85.53  (15.09) 56.10  (19.30) 89.23  (23.86)
Day 85 Number Analyzed 12 participants 6 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-4.37  (3.11) 41.36  (11.92) 19.11  (9.44) 63.71  (11.99) 77.23  (16.82) 48.66  (12.49) 81.93  (31.34)
Day 99 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-4.97  (3.94) 21.81  (7.95) -9.45  (6.47) 49.49  (16.14) 31.98  (6.31) 33.70  (18.41) 30.28  (26.45)
Day 113 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
2.57  (4.85) 4.81  (8.41) -11.70  (6.94) 31.46  (10.14) 20.24  (15.41) 12.25  (12.11) 6.17  (10.83)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-0.34  (4.46) 2.79  (13.64) -13.58  (4.48) 24.45  (15.36) 152.92  (144.30) 5.06  (14.88) -3.88  (11.30)
Day 141 Number Analyzed 11 participants 6 participants 6 participants 5 participants 4 participants 5 participants 6 participants
-3.80  (3.25) -2.99  (8.22) -25.33  (10.05) 21.63  (8.86) 17.25  (9.58) 8.58  (9.20) -4.33  (7.28)
Day 155 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-3.51  (4.78) -6.23  (7.52) -21.04  (7.35) 7.69  (8.01) 6.85  (14.51) -7.10  (10.56) -11.15  (14.79)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants
1.25  (5.30) -7.12  (7.84) -20.27  (8.66) 16.81  (12.43) 24.60  (12.75) 2.19  (10.84) -13.66  (10.56)
16.Secondary Outcome
Title Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)
Hide Description [Not Specified]
Time Frame Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 2 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-0.07  (2.80) -4.51  (3.09) -8.52  (3.73) 10.25  (3.50) 2.22  (4.04) 5.82  (2.73) -0.80  (4.20)
Day 4 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
2.16  (3.11) -2.74  (4.96) -4.52  (7.52) 13.74  (3.39) 1.15  (6.14) 8.29  (6.28) 6.68  (3.66)
Day 6 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
2.26  (3.85) 11.82  (7.95) 7.76  (3.93) 14.17  (2.52) 12.59  (4.56) 3.64  (6.40) 6.93  (1.29)
Day 8 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-3.30  (5.72) 20.02  (10.24) 9.69  (4.75) 21.51  (6.34) 21.87  (9.57) 24.20  (14.92) 20.98  (2.05)
Day 15 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-3.26  (3.45) 31.67  (14.36) 31.96  (6.28) 33.68  (8.61) 51.97  (5.28) 15.58  (4.69) 46.38  (8.63)
Day 22 Number Analyzed 12 participants 6 participants 5 participants 6 participants 6 participants 5 participants 6 participants
1.23  (3.14) 39.83  (11.04) 37.30  (4.15) 58.45  (14.40) 57.66  (9.91) 27.74  (7.34) 61.39  (14.64)
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-2.04  (2.94) 56.09  (19.29) 36.50  (8.85) 65.10  (14.72) 61.66  (13.21) 36.74  (10.53) 35.63  (13.78)
Day 36 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
0.04  (3.62) 54.87  (14.40) 28.89  (7.65) 72.39  (12.18) 63.55  (10.27) 43.48  (7.98) 34.27  (7.92)
Day 43 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-1.93  (5.02) 49.26  (14.03) 39.33  (10.46) 68.54  (12.84) 66.74  (10.38) 27.55  (8.68) 52.27  (13.48)
Day 50 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-5.81  (4.23) 45.38  (15.81) 68.67  (11.00) 34.97  (10.37)
Day 57 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-2.15  (5.99) 41.39  (11.28) 38.07  (11.16) 65.28  (9.34) 47.38  (6.06) 38.47  (12.18) 44.53  (11.57)
Day 58 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
-2.79  (8.79) 29.12  (12.18) 39.33  (5.29) 44.24  (13.63)
Day 60 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
-7.26  (5.69) 18.64  (9.41) 38.07  (7.47) 36.75  (11.16)
Day 62 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 5 participants
-8.41  (5.03) 24.58  (10.61) 38.52  (7.59) 31.71  (10.53)
Day 64 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-8.42  (5.15) 34.60  (12.41) 19.54  (5.71) 77.50  (10.29) 38.38  (7.43) 27.78  (13.26) 45.24  (9.78)
Day 71 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
-8.14  (4.26) 34.29  (11.32) 16.29  (6.39) 52.77  (7.72) 44.72  (9.30) 25.46  (15.12) 47.47  (9.99)
Day 72 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-7.83  (3.96) 32.18  (12.27) 50.19  (10.57) 19.60  (10.46)
Day 74 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-11.97  (7.31) 20.46  (15.03) 57.85  (10.91) 15.07  (13.92)
Day 76 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 4 participants 0 participants
-9.30  (5.16) 40.67  (12.44) 51.82  (9.53) 17.91  (12.86)
Day 78 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-3.54  (4.26) 33.07  (12.20) 19.74  (6.38) 64.46  (11.16) 43.30  (14.16) 13.37  (7.30) 47.07  (12.38)
Day 85 Number Analyzed 12 participants 6 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-1.70  (3.61) 26.01  (12.18) 7.70  (5.59) 69.90  (21.35) 38.27  (4.20) 18.68  (9.63) 42.53  (14.53)
Day 99 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-3.35  (4.67) 23.36  (10.68) -1.91  (3.22) 24.89  (14.52) 5.10  (1.62) 17.55  (17.51) 13.75  (6.54)
Day 113 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
7.31  (6.57) 10.26  (9.51) -3.15  (3.85) 14.75  (5.08) -5.26  (10.20) -6.58  (3.92) 14.50  (5.38)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.52  (5.26) -2.73  (7.12) -2.30  (4.12) 9.62  (6.27) 1.13  (6.36) -6.54  (7.54) 5.26  (5.75)
Day 141 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
2.55  (5.44) -1.68  (6.67) -5.98  (5.03) 2.90  (7.10) 3.75  (3.96) -4.71  (4.43) 9.34  (3.25)
Day 155 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
5.25  (5.28) -0.82  (6.82) -4.10  (4.67) 6.15  (4.92) 5.12  (6.77) -4.11  (3.38) 6.78  (8.32)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants
3.90  (5.22) -1.37  (6.27) -5.72  (5.75) 2.33  (4.19) 16.26  (7.56) -4.76  (5.36) -0.42  (6.39)
17.Secondary Outcome
Title Percent Change From Baseline in Serum C-telopeptide (sCTX)
Hide Description [Not Specified]
Time Frame Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 2 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-7.31  (4.30) 12.29  (9.15) -11.32  (4.22) 8.05  (9.96) -7.07  (7.36) -10.15  (10.74) -6.57  (3.50)
Day 4 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-5.51  (5.87) 1.10  (12.49) -19.03  (9.12) -26.84  (4.63) -25.85  (7.05) -22.01  (3.66) -34.13  (3.28)
Day 6 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-12.60  (5.74) -8.29  (12.56) -26.11  (10.32) -28.04  (7.70) -36.98  (5.38) -28.83  (6.44) -35.78  (3.37)
Day 8 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-17.79  (5.06) -14.65  (11.02) -31.59  (10.22) -28.92  (3.05) -35.93  (3.90) -42.09  (4.09) -43.93  (3.44)
Day 15 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-18.86  (5.92) -14.39  (9.41) -35.11  (8.69) -35.27  (4.30) -33.00  (7.65) -39.34  (2.85) -48.74  (5.56)
Day 22 Number Analyzed 12 participants 6 participants 5 participants 6 participants 6 participants 5 participants 6 participants
-12.98  (6.18) -4.88  (9.99) -29.97  (12.42) -37.34  (3.50) -22.85  (7.88) -36.63  (6.67) -39.21  (4.70)
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 6 participants 6 participants
-10.94  (6.87) 0.31  (6.08) -21.11  (8.86) -25.43  (6.08) -21.54  (10.95) -32.76  (4.85) -34.53  (8.14)
Day 36 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-20.96  (7.87) 4.50  (11.96) -21.42  (12.02) -38.33  (2.21) -29.20  (15.71) -36.51  (9.31) -50.32  (4.78)
Day 43 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-14.14  (7.40) 3.91  (9.40) -13.79  (15.06) -34.04  (3.35) -20.49  (12.73) -28.54  (6.07) -44.64  (7.31)
Day 50 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-12.62  (7.98) -4.78  (11.11) -26.11  (5.90) -22.42  (15.96)
Day 57 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-17.59  (6.11) 14.35  (10.32) -4.53  (17.99) -23.74  (6.45) -13.47  (15.73) -25.25  (12.27) -31.52  (7.89)
Day 58 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
-20.27  (7.58) -9.15  (9.82) -9.63  (15.05) -28.19  (8.64)
Day 60 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
-14.95  (10.06) -8.80  (13.64) -22.34  (16.06) -28.04  (11.68)
Day 62 Number Analyzed 6 participants 0 participants 5 participants 0 participants 5 participants 0 participants 5 participants
-14.01  (10.87) -25.09  (10.87) -21.83  (18.62) -41.37  (8.69)
Day 64 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-10.22  (7.59) 6.59  (16.03) -20.16  (8.81) -20.09  (4.55) -18.72  (14.04) -20.03  (12.81) -34.86  (10.25)
Day 71 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
-15.23  (5.58) 26.63  (14.92) -14.42  (11.82) -18.24  (7.26) -14.03  (13.60) -11.02  (18.12) -38.38  (4.37)
Day 72 Number Analyzed 6 participants 6 participants 0 participants 5 participants 0 participants 5 participants 0 participants
-19.21  (6.72) 11.70  (13.66) -17.32  (7.84) -8.98  (16.64)
Day 74 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-6.15  (8.32) 7.40  (11.86) -16.32  (6.94) -9.80  (14.64)
Day 76 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-19.35  (5.70) 11.70  (9.88) -17.14  (9.24) -17.12  (13.70)
Day 78 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-18.50  (6.03) 9.18  (11.45) -14.82  (10.85) -17.99  (10.44) 11.88  (21.63) -5.24  (18.22) -21.66  (11.50)
Day 85 Number Analyzed 12 participants 6 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-12.69  (5.84) 14.95  (13.45) 8.97  (10.90) -13.06  (9.08) 13.77  (22.18) -16.89  (16.84) -17.17  (10.09)
Day 99 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-20.31  (5.21) 7.45  (8.41) -15.79  (9.03) -7.79  (8.64) -5.14  (17.67) -13.22  (17.06) -8.18  (10.80)
Day 113 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-15.61  (6.74) 4.66  (11.35) -18.77  (12.28) 0.18  (13.58) -7.88  (13.06) -10.06  (10.22) -8.20  (12.19)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-19.03  (5.79) -5.63  (13.21) -12.96  (12.78) 0.46  (10.01) -4.92  (18.73) 1.68  (14.91) -16.92  (13.00)
Day 141 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-21.10  (6.53) 4.86  (10.74) -12.11  (14.71) 1.99  (9.89) 13.34  (14.80) -22.48  (5.32) -21.35  (9.69)
Day 155 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-21.03  (5.72) -0.02  (8.21) -3.37  (12.01) 7.94  (6.33) 1.27  (14.71) -14.43  (12.92) -15.00  (14.96)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants
-16.59  (6.74) -1.13  (8.37) -9.38  (12.56) -0.92  (15.29) -0.27  (10.41) -15.61  (11.74) -10.10  (9.54)
18.Secondary Outcome
Title Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Hide Description [Not Specified]
Time Frame Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 2 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-5.72  (4.12) -13.34  (6.82) -2.09  (12.69) 7.94  (4.48) -1.06  (5.09) 8.68  (5.69) -5.04  (8.62)
Day 4 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-18.14  (2.42) 0.35  (13.61) 18.59  (17.92) 2.94  (19.63) 1.34  (10.38) -5.59  (31.57) -3.14  (14.09)
Day 6 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-22.64  (5.59) -2.67  (8.79) 23.15  (15.52) 8.42  (17.70) 43.89  (18.45) 20.35  (21.69) -4.22  (11.74)
Day 8 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-22.84  (5.19) -0.20  (6.59) 16.68  (13.79) -7.82  (8.93) 12.58  (13.18) -2.24  (9.43) 9.33  (24.92)
Day 15 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-8.84  (5.93) 7.31  (12.26) 18.72  (12.98) -10.00  (7.92) 67.27  (35.74) -1.40  (14.42) 12.46  (27.05)
Day 22 Number Analyzed 12 participants 6 participants 5 participants 6 participants 6 participants 5 participants 6 participants
-9.12  (4.45) 63.58  (41.80) 28.93  (15.69) 0.65  (17.49) 69.17  (22.48) 24.27  (21.16) 48.13  (37.16)
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-7.45  (6.70) 26.13  (14.71) 41.90  (10.87) 34.10  (25.51) 41.45  (17.60) 23.91  (21.12) 3.68  (19.02)
Day 36 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-14.24  (4.63) 25.21  (11.90) 57.32  (15.99) 22.33  (25.29) 54.47  (18.24) 37.99  (26.79) 10.94  (14.70)
Day 43 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-14.84  (5.36) 28.17  (11.49) 47.38  (19.72) 23.77  (26.38) 73.55  (22.75) 39.90  (17.90) 37.55  (31.09)
Day 50 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-7.02  (9.81) 30.25  (19.47) 34.06  (31.75) 41.77  (27.38)
Day 57 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-13.17  (6.57) 66.13  (35.48) 31.59  (25.03) 26.12  (20.92) 26.23  (13.73) 26.14  (26.62) 23.55  (28.82)
Day 58 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
-10.21  (7.73) 34.80  (16.82) 57.65  (25.32) 24.71  (15.33)
Day 60 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 6 participants
-8.41  (9.17) 52.00  (20.18) 72.18  (16.59) 56.06  (31.40)
Day 62 Number Analyzed 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants 5 participants
-2.33  (10.30) 48.83  (20.01) 47.94  (18.36) 37.93  (22.34)
Day 64 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-6.40  (8.29) 19.81  (11.29) 62.54  (17.33) 30.11  (13.35) 62.07  (18.54) 49.59  (26.25) 64.46  (31.92)
Day 71 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
-10.38  (3.86) 21.65  (17.69) 40.97  (15.06) 7.80  (17.50) 68.44  (26.27) 11.07  (24.13) 15.84  (12.81)
Day 72 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-19.26  (8.34) 32.07  (19.22) 41.99  (35.57) 30.65  (17.43)
Day 74 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 5 participants 0 participants
-9.74  (6.73) 32.25  (25.26) 21.37  (17.25) 71.86  (39.62)
Day 76 Number Analyzed 6 participants 6 participants 0 participants 6 participants 0 participants 4 participants 0 participants
-8.27  (6.56) 32.24  (14.18) 2.58  (14.33) 20.58  (20.98)
Day 78 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-16.60  (5.70) 21.00  (14.55) 44.03  (11.32) 31.00  (22.68) 56.98  (25.29) 28.62  (13.12) 22.73  (27.28)
Day 85 Number Analyzed 12 participants 6 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-3.49  (5.98) 16.48  (11.90) 47.95  (9.94) -3.99  (13.52) 24.90  (19.86) 33.55  (22.61) 29.25  (25.49)
Day 99 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-20.78  (5.77) 20.49  (13.44) 14.08  (7.81) 5.91  (26.94) 12.34  (11.46) 3.12  (12.69) 2.69  (19.10)
Day 113 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-7.05  (7.87) 0.16  (12.53) 13.91  (11.95) -5.87  (11.21) -10.83  (19.52) 13.19  (18.27) 16.73  (18.23)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-12.50  (5.08) -16.74  (7.08) 3.14  (14.76) -11.32  (7.81) -7.07  (6.79) -2.02  (17.24) 6.96  (13.62)
Day 141 Number Analyzed 11 participants 6 participants 6 participants 5 participants 4 participants 5 participants 6 participants
-16.41  (3.26) -5.85  (9.79) -8.33  (8.30) -19.91  (6.71) -4.19  (6.92) -16.85  (13.53) 10.80  (18.12)
Day 155 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-15.06  (4.78) 1.27  (8.24) 10.09  (11.69) -15.78  (7.72) 17.62  (9.94) -3.50  (10.45) 8.76  (16.71)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants
-9.95  (7.25) -18.84  (7.75) -10.08  (13.08) -19.71  (9.00) 30.72  (20.07) -3.01  (10.49) 15.09  (21.69)
19.Secondary Outcome
Title Percent Change From Baseline in Sclerostin
Hide Description [Not Specified]
Time Frame Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available data at baseline and each time point
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Error)
Unit of Measure: percent change
Day 15 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 5 participants 6 participants
-5.6  (4.7) 3135.6  (665.6) 5630.4  (478.9) 6087.5  (651.1) 7532.4  (627.8) 2809.3  (241.8) 6816.0  (775.1)
Day 29 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
-3.6  (5.4) 4068.2  (923.8) 2335.8  (283.2) 7713.1  (997.9) 4993.3  (890.2) 3904.4  (399.2) 4573.0  (614.4)
Day 43 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
4.4  (8.5) 4669.2  (1119.6) 6229.6  (475.2) 9023.8  (1003.7) 8471.0  (506.6) 4613.9  (486.2) 6486.0  (621.2)
Day 57 Number Analyzed 12 participants 6 participants 6 participants 6 participants 5 participants 5 participants 6 participants
0.4  (7.2) 5143.9  (1145.2) 3024.9  (290.7) 8450.2  (545.0) 6137.5  (1319.7) 4450.8  (471.5) 4739.5  (660.2)
Day 71 Number Analyzed 12 participants 6 participants 5 participants 6 participants 5 participants 5 participants 6 participants
-1.9  (5.7) 4949.6  (1133.1) 6905.1  (875.7) 10130.3  (1041.3) 9114.5  (812.4) 5405.1  (667.6) 7735.8  (949.8)
Day 85 Number Analyzed 12 participants 6 participants 5 participants 6 participants 4 participants 5 participants 6 participants
-2.2  (5.8) 4886.5  (1085.4) 3004.2  (538.5) 10566.4  (1667.4) 5403.5  (1285.7) 5254.5  (588.9) 4873.7  (520.7)
Day 99 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-3.5  (6.9) 2496.0  (806.8) 952.8  (362.7) 6748.3  (1165.3) 2124.2  (736.4) 1960.4  (461.1) 2183.7  (520.7)
Day 113 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
-7.3  (6.5) 883.2  (397.5) 399.4  (175.9) 3556.2  (627.9) 473.3  (129.2) 395.4  (57.0) 804.9  (257.7)
Day 127 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
0.2  (5.8) 364.9  (185.9) 161.5  (67.9) 1410.2  (273.0) 202.6  (58.2) 242.5  (150.0) 311.3  (117.9)
Day 141 Number Analyzed 11 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
2.1  (7.5) 203.9  (110.6) 84.6  (47.3) 524.3  (109.9) 178.2  (101.5) 74.2  (25.5) 128.2  (61.5)
Day 155 Number Analyzed 12 participants 6 participants 6 participants 6 participants 4 participants 5 participants 6 participants
2.6  (9.0) 118.8  (78.9) 57.4  (35.5) 298.6  (67.4) 41.0  (21.8) 88.6  (43.3) 48.3  (36.6)
Day 169 Number Analyzed 12 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants
1.9  (9.1) 76.1  (37.7) 40.3  (27.8) 177.3  (37.8) 845.3  (528.9) 713.7  (688.9) 16.8  (20.9)
20.Secondary Outcome
Title Change From Baseline in Ionized Calcium
Hide Description [Not Specified]
Time Frame Baseline and day 169 (or earlier for participants who discontinued before day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description:
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W).
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
Overall Number of Participants Analyzed 12 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.05  (0.17) 0.12  (0.10) 0.06  (0.21) -0.07  (0.18) -0.05  (0.04) -0.14  (0.18) -0.06  (0.14)
Time Frame 169 days
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Hide Arm/Group Description Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months.
All-Cause Mortality
Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   1/6 (16.67%) 
Blood and lymphatic system disorders               
HAEMORRHAGIC ANAEMIA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders               
CORONARY ARTERY DISEASE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders               
HAEMATOCHEZIA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Romosozumab 1 mg/kg Q2W in Women Romosozumab 2 mg/kg Q4W in Women Romosozumab 2 mg/kg Q2W in Women Romosozumab 3 mg/kg Q4W in Women Romosozumab 1 mg/kg Q2W in Men Romosozumab 3 mg/kg Q4W in Men
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/12 (83.33%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   5/6 (83.33%)   5/6 (83.33%)   5/6 (83.33%) 
Blood and lymphatic system disorders               
ANAEMIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
LYMPHADENOPATHY  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders               
CORONARY ARTERY DISEASE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
PALPITATIONS  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders               
EAR PAIN  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders               
CONJUNCTIVAL HYPERAEMIA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
OCULAR HYPERAEMIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
VISION BLURRED  1  3/12 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders               
ABDOMINAL PAIN  1  1/12 (8.33%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
ABDOMINAL PAIN UPPER  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
COLONIC POLYP  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
CONSTIPATION  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DENTAL CARIES  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DIARRHOEA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
DIVERTICULUM INTESTINAL  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
DYSPEPSIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
FLATULENCE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
GINGIVAL ULCERATION  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
HAEMORRHOIDAL HAEMORRHAGE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
LIP ULCERATION  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
NAUSEA  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
SWOLLEN TONGUE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
VOMITING  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
General disorders               
ASTHENIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
AXILLARY PAIN  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
CHEST PAIN  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
FATIGUE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
FEELING COLD  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/12 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE BRUISING  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE DISCOMFORT  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE ERYTHEMA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE INDURATION  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE IRRITATION  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE PAIN  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
INJECTION SITE REACTION  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%) 
OEDEMA PERIPHERAL  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
SENSATION OF FOREIGN BODY  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
VENIPUNCTURE SITE SWELLING  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Immune system disorders               
HYPERSENSITIVITY  1  0/12 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
SEASONAL ALLERGY  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Infections and infestations               
BRONCHITIS  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
FUNGAL SKIN INFECTION  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
GASTROENTERITIS VIRAL  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INFECTED INSECT BITE  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
NASOPHARYNGITIS  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
SINUSITIS  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/12 (8.33%)  3/6 (50.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%) 
URINARY TRACT INFECTION  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
VULVITIS  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications               
ARTHROPOD BITE  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
BACK INJURY  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
CONTUSION  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
FOOT FRACTURE  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
LACERATION  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
LIGAMENT INJURY  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations               
BLOOD PRESSURE INCREASED  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
CARDIAC MURMUR  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
HEART RATE INCREASED  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders               
ANOREXIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
HYPOCALCAEMIA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders               
ARTHRALGIA  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%) 
BACK PAIN  1  2/12 (16.67%)  3/6 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
BURSITIS  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
FIBROMYALGIA  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
JOINT EFFUSION  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCLE SPASMS  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCULAR WEAKNESS  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCULOSKELETAL PAIN  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
MYALGIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
PAIN IN EXTREMITY  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%) 
SENSATION OF HEAVINESS  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
SYNOVIAL CYST  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
TRIGGER FINGER  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
SKIN PAPILLOMA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders               
DIZZINESS  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DYSGEUSIA  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
HEADACHE  1  4/12 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  3/6 (50.00%)  2/6 (33.33%) 
LETHARGY  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
MULTIPLE SCLEROSIS  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
RESTLESS LEGS SYNDROME  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
SOMNOLENCE  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Psychiatric disorders               
ANXIETY  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DEPRESSION  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INSOMNIA  1  1/12 (8.33%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders               
DYSURIA  1  0/12 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
POLLAKIURIA  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders               
VULVOVAGINAL BURNING SENSATION  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
VULVOVAGINAL PRURITUS  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
COUGH  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
DRY THROAT  1  1/12 (8.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
EPISTAXIS  1  0/12 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
NASAL CONGESTION  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
OROPHARYNGEAL PAIN  1  2/12 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
RHINITIS ALLERGIC  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
RHINORRHOEA  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders               
ACTINIC KERATOSIS  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
PRURITUS  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
RASH PAPULAR  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders               
HAEMATOMA  1  0/12 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
HYPERTENSION  1  0/12 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01825785     History of Changes
Other Study ID Numbers: 20060221
First Submitted: January 25, 2013
First Posted: April 8, 2013
Results First Submitted: April 10, 2019
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019