Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 108 for:    CALCIUM CATION

A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059435
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : July 4, 2019
Last Update Posted : July 4, 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
Condition Osteopenia
Interventions Drug: Romosozumab
Drug: Placebo
Enrollment 74
Recruitment Details This was a single-center study conducted in the USA. The first participant enrolled on 13 December 2006 and the last participant completed the study on 06 July 2007.
Pre-assignment Details Participants were enrolled sequentially into 1 of 6 dose cohorts. Healthy postmenopausal women were randomized to romosozumab or placebo in a 3:1 ratio at 0.1, 0.3, 1 mg/kg SC, 1 mg/kg IV, 3, 5 mg/kg SC, 10 mg/kg SC, or 10 mg/kg IV; healthy men received romosozumab SC or IV, placebo SC or IV in a 3:3:1:1 ratio at doses of 1 mg/kg or 10 mg/kg.
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description Participants received a single subcutaneous (SC) injection of matching placebo. Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab. Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab. Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab. Participants received a single intravenous (IV) injection of matching placebo. Participants received a single intravenous injection of 1.0 mg/kg romosozumab. Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Period Title: Overall Study
Started 14 6 8 9 6 9 6 4 6 6
Received Study Drug 14 6 6 9 6 9 6 4 6 6
Completed 14 6 6 9 6 9 6 4 6 6
Not Completed 0 0 2 0 0 0 0 0 0 0
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV Total
Hide Arm/Group Description Participants received a single subcutaneous (SC) injection of matching placebo. Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab. Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab. Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab. Participants received a single intravenous (IV) injection of matching placebo. Participants received a single intravenous injection of 1.0 mg/kg romosozumab. Participants received a single intravenous injection of 5.0 mg/kg romosozumab Total of all reporting groups
Overall Number of Baseline Participants 14 6 6 9 6 9 6 4 6 6 72
Hide Baseline Analysis Population Description
All treated participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants 72 participants
SC Dosing 52.79  (4.17) 53.00  (3.95) 53.33  (3.20) 52.00  (4.64) 55.00  (4.05) 51.89  (2.32) 52.50  (4.32) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 52.80  (3.79)
IV Dosing NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 52.50  (4.43) 49.33  (4.63) 51.00  (3.35) 50.75  (4.06)
[1]
SC dosing cohorts are reported in this row
[2]
IV dosing cohorts are reported in this row
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants 72 participants
Female
12
  85.7%
6
 100.0%
6
 100.0%
6
  66.7%
6
 100.0%
6
  66.7%
6
 100.0%
2
  50.0%
3
  50.0%
3
  50.0%
56
  77.8%
Male
2
  14.3%
0
   0.0%
0
   0.0%
3
  33.3%
0
   0.0%
3
  33.3%
0
   0.0%
2
  50.0%
3
  50.0%
3
  50.0%
16
  22.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants 72 participants
White or Caucasian
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
2
  50.0%
1
  16.7%
0
   0.0%
6
   8.3%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   1.4%
Hispanic or Latino
12
  85.7%
6
 100.0%
6
 100.0%
9
 100.0%
6
 100.0%
9
 100.0%
5
  83.3%
2
  50.0%
4
  66.7%
6
 100.0%
65
  90.3%
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 Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
9
  64.3%
4
  66.7%
4
  66.7%
1
  11.1%
5
  83.3%
6
  66.7%
5
  83.3%
2
  50.0%
1
  16.7%
2
  33.3%
Serious adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
Treatment-related adverse events
5
  35.7%
4
  66.7%
2
  33.3%
0
   0.0%
3
  50.0%
4
  44.4%
5
  83.3%
0
   0.0%
1
  16.7%
1
  16.7%
Serious treatment-related adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
Discontinuations due to adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
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 Anti-romosozumab Antibodies
Hide Description Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.
Time Frame Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Measure Type: Number
Unit of Measure: participants
Binding antibody positive 0 0 0 0 0 2 2 0 0 2
Neutralizing antibody positive 0 0 0 0 0 0 1 0 0 0
3.Secondary Outcome
Title Maximum Observed Concentration (Cmax) of Romosozumab
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received subcutaneous romosozumab
Arm/Group Title Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC
Hide Arm/Group Description:
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Overall Number of Participants Analyzed 6 6 9 6 9 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
375  (182) 1280  (653) 4890  (1780) 21300  (5170) 33500  (8290) 75200  (15900)
4.Secondary Outcome
Title Time to Maximum Observed Concentration (Tmax) of Romosozumab
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received subcutaneous romosozumab
Arm/Group Title Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC
Hide Arm/Group Description:
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Overall Number of Participants Analyzed 6 6 9 6 9 6
Median (Full Range)
Unit of Measure: days
1.5
(0.5 to 7)
2.5
(2 to 5)
3
(2 to 14)
5
(4 to 7)
5
(3 to 7)
4.5
(2 to 7)
5.Secondary Outcome
Title Initial Concentration Following IV Administration (C0) of Romosozumab
Hide Description [Not Specified]
Time Frame Day 1 at the end of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received intravenously administered romosozumab
Arm/Group Title Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
24900  (4670) 132000  (13700)
6.Secondary Outcome
Title Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received romosozumab
Arm/Group Title Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 6 6 9 6 9 6 6 6
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
78.5  (22.6) 288  (144) 1480  (605) 8170  (1810) 16900  (4350) 43400  (8550) 3020  (989) 24400  (4400)
7.Secondary Outcome
Title Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received romosozumab
Arm/Group Title Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 6 6 9 6 9 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/hr/kg
1.39  (0.489) 1.35  (0.841) 0.873  (0.647) 0.383  (0.0901) 0.319  (0.0998) 0.236  (0.0370) 0.362  (0.117) 0.210  (0.0361)
8.Secondary Outcome
Title Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab
Hide Description The plateau (beta, β) phase half-life (t½,β) was calculated from the natural log of 2 divided by the beta phase rate constant (λβ). λβ for a subject was estimated by linear regression of at least 3 contiguous time points that followed the Cmax and constituted a distinct phase that preceded the terminal phase.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received 3, 5, or 10 mg/kg romosozumab
Arm/Group Title Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 0 0 0 6 9 6 0 6
Mean (Standard Deviation)
Unit of Measure: days
11.1  (3.70) 12.9  (3.14) 18.0  (3.54) 10.6  (1.70)
9.Secondary Outcome
Title Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab
Hide Description The terminal (gamma, γ) phase half-life (t½,γ) was calculated from the natural log of 2 divided by the terminal rate constant (λz).
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received romosozumab
Arm/Group Title Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 6 6 9 6 9 6 6 6
Mean (Standard Deviation)
Unit of Measure: days
5.20  (1.36) 5.13  (0.640) 5.50  (0.322) 6.68  (0.961) 5.81  (0.874) 5.88  (1.60) 4.49  (0.974) 4.93  (0.639)
10.Secondary Outcome
Title Maximum Effect for Serum Type 1 Aminoterminal Propeptide (P1NP)
Hide Description Defined as the maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
69.8  (32.0) 57.7  (22.8) 60.9  (14.4) 60.7  (10.8) 100.8  (49.6) 125.1  (44.2) 141.4  (24.8) 77.0  (35.3) 76.3  (19.8) 173.4  (43.3)
11.Secondary Outcome
Title Time to Maximum Effect of P1NP
Hide Description Defined as the time to maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Median (Full Range)
Unit of Measure: days
39.5
(1.0 to 64.0)
11.0
(6.0 to 29.0)
4.5
(1.0 to 15.0)
15.0
(11.0 to 57.0)
22.0
(15.0 to 22.0)
22.0
(15.0 to 29.0)
25.5
(22.0 to 36.0)
43.0
(1.0 to 57.0)
15.0
(11.0 to 22.0)
18.5
(15.0 to 29.0)
12.Secondary Outcome
Title Area Under the Curve From Day 0 to Day 29 (AUC0-29) for P1NP
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*ng/mL
1529  (633) 1431  (548) 1564  (377) 1473  (304) 2300  (1099) 2780  (1007) 2986  (306) 1714  (782) 1794  (434) 3940  (944)
13.Secondary Outcome
Title Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for P1NP
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab,
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*ng/mL
3234  (1462) 1431  (548) 1564  (377) 2782  (513) 3962  (1702) 6759  (2434) 7846  (1264) 4487  (2352) 3138  (723) 8976  (2531)
14.Secondary Outcome
Title Maximum Effect for Serum C-telopeptide (sCTX)
Hide Description Defined as the minimum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.3  (0.2) 0.4  (0.2) 0.3  (0.1) 0.3  (0.1) 0.4  (0.1) 0.2  (0.1) 0.2  (0.1) 0.3  (0.2) 0.2  (0.1) 0.2  (0.1)
15.Secondary Outcome
Title Time to Maximum Effect of sCTX
Hide Description Defined as the time to minimum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Median (Full Range)
Unit of Measure: days
1.0
(1.0 to 36.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 43.0)
1.0
(1.0 to 50.0)
8.0
(1.0 to 78.0)
6.0
(1.0 to 22.0)
18.5
(1.0 to 43.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 64.0)
16.Secondary Outcome
Title Area Under the Curve From Day 0 to Day 29 (AUC0-29) for sCTX
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*ng/mL
20  (8) 21  (6) 18  (5) 15  (6) 14  (3) 11  (4) 8  (3) 21  (8) 13  (3) 12  (5)
17.Secondary Outcome
Title Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for sCTX
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*ng/mL
37  (18) 21  (6) 18  (5) 30  (13) 29  (7) 41  (18) 40  (15) 44  (20) 26  (6) 44  (13)
18.Secondary Outcome
Title Maximum Effect for Osteocalcin
Hide Description Defined as the maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: µg/L
28.9  (8.1) 25.6  (8.0) 25.8  (4.8) 26.6  (5.5) 36.9  (10.9) 39.0  (12.7) 53.9  (10.5) 35.9  (13.9) 28.8  (7.7) 53.5  (12.8)
19.Secondary Outcome
Title Time to Maximum Effect of Osteocalcin
Hide Description Defined as the time to maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Median (Full Range)
Unit of Measure: days
29.0
(2.0 to 57.0)
15.0
(2.0 to 15.0)
18.5
(2.0 to 38.0)
22.0
(11.0 to 36.0)
22.0
(22.0 to 29.0)
29.0
(29.0 to 50.0)
36.0
(26.0 to 57.0)
34.0
(5.0 to 64.0)
22.0
(11.0 to 36.0)
32.5
(29.0 to 43.0)
20.Secondary Outcome
Title Area Under the Curve From Day 0 to Day 29 (AUC0-29) for Osteocalcin
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*µg/L
617  (209) 611  (191) 658  (153) 570  (139) 753  (234) 757  (225) 881  (162) 759  (286) 559  (73) 973  (212)
21.Secondary Outcome
Title Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for Osteocalcin
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*µg/L
1259  (505) 611  (191) 658  (153) 1129  (256) 1487  (453) 2470  (827) 2964  (563) 1897  (519) 1132  (131) 2988  (460)
22.Secondary Outcome
Title Maximum Effect for Bone-specific Alkaline Phosphatase (BSAP)
Hide Description Defined as the maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: µg/L
21.0  (5.7) 18.0  (6.7) 17.2  (3.2) 17.7  (4.7) 26.1  (7.8) 24.6  (8.6) 29.9  (8.2) 19.6  (3.7) 15.9  (4.5) 36.4  (15.9)
23.Secondary Outcome
Title Time to Maximum Effect of BSAP
Hide Description Defined as the time to maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Median (Full Range)
Unit of Measure: days
36.0
(4.0 to 78.0)
16.5
(4.0 to 29.0)
13.0
(6.0 to 19.0)
15.0
(8.0 to 29.0)
22.0
(22.0 to 22.0)
22.0
(22.0 to 36.0)
22.0
(15.0 to 29.0)
46.5
(6.0 to 85.0)
13.5
(6.0 to 50.0)
29.0
(22.0 to 36.0)
24.Secondary Outcome
Title Area Under the Curve From Day 0 to Day 29 (AUC0-29) for BSAP
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*µg/L
462  (157) 460  (172) 460  (127) 422  (100) 588  (152) 540  (210) 639  (176) 448  (73) 376  (102) 780  (325)
25.Secondary Outcome
Title Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*µg/L
958  (428) 460  (172) 460  (127) 815  (190) 1120  (303) 1496  (527) 1860  (508) 1138  (191) 731  (177) 2033  (780)
26.Secondary Outcome
Title Maximum Effect for Intact Parathyroid Hormone (iPTH)
Hide Description Defined as the maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: ng/L
43.3  (12.6) 38.7  (11.9) 54.5  (13.1) 49.9  (20.5) 62.8  (10.9) 66.0  (20.0) 76.3  (15.7) 64.8  (27.8) 52.7  (20.1) 59.7  (14.9)
27.Secondary Outcome
Title Time to Maximum Effect of iPTH
Hide Description Defined as the time to maximum value postdose.
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Median (Full Range)
Unit of Measure: days
11.0
(1.0 to 71.0)
11.0
(1.0 to 15.0)
25.5
(15.0 to 29.0)
22.0
(3.0 to 43.0)
22.0
(1.0 to 29.0)
22.0
(8.0 to 50.0)
15.0
(1.0 to 50.0)
25.5
(1.0 to 71.0)
11.0
(1.0 to 57.0)
18.5
(8.0 to 43.0)
28.Secondary Outcome
Title Area Under the Curve From Day 0 to Day 29 (AUC0-29) for iPTH
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*ng/L
817  (295) 823  (202) 1234  (341) 1002  (405) 1270  (198) 1240  (342) 1422  (411) 1235  (488) 1074  (406) 1239  (267)
29.Secondary Outcome
Title Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH
Hide Description [Not Specified]
Time Frame Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: days*ng/L
1592  (689) 823  (202) 1234  (341) 1971  (850) 2523  (406) 3483  (1057) 4195  (1144) 3100  (1077) 2072  (749) 3515  (1127)
30.Secondary Outcome
Title Percent Change From Baseline in Sclerostin
Hide Description [Not Specified]
Time Frame Baseline and days 15, 29, 43, 57, 71, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed on days 71 and 85.
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: percent change
Day 15 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
53.2  (54.3) 465.5  (49.9) 835.1  (130.4) 2123.8  (377.6) 7965.9  (792.9) 12375.7  (1375.4) 17774.8  (2444.0) 6.7  (11.4) 3776.0  (461.5) 14230.0  (2428.1)
Day 29 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
-8.4  (7.0) 129.0  (33.3) 183.0  (19.6) 717.4  (92.4) 5140.2  (373.7) 9763.2  (1252.8) 18870.9  (2707.3) -4.3  (8.7) 816.7  (222.3) 11715.5  (2177.0)
Day 43 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
-9.8  (14.1) 223.2  (18.1) 1988.3  (339.9) 4968.7  (714.7) 13902.7  (2381.9) 4.9  (8.7) 196.1  (48.7) 4576.0  (1086.7)
Day 57 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
-3.7  (8.6) 83.4  (14.5) 810.2  (169.9) 2004.9  (421.5) 6469.6  (1000.3) 15.6  (0.6) 49.9  (17.4) 1430.0  (538.0)
Day 71 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
86.9  (88.3) 610.4  (151.6) 2080.8  (689.0) -5.5  (5.4) 426.9  (119.6)
Day 85 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
11.6  (16.6) 232.1  (49.0) 758.0  (270.1) 0.8  (13.4) 109.8  (30.6)
31.Secondary Outcome
Title Serum Calcium Over Time
Hide Description [Not Specified]
Time Frame Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 1 Pre-dose Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.49  (0.34) 9.45  (0.38) 9.50  (0.33) 9.48  (0.27) 9.42  (0.25) 9.53  (0.26) 9.38  (0.24) 9.60  (0.22) 9.23  (0.15) 9.37  (0.15)
Day 1 Hour 4 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.46  (0.30) 9.62  (0.19) 9.45  (0.26) 9.38  (0.16) 9.38  (0.15) 9.59  (0.27) 9.35  (0.40) 9.45  (0.21) 9.43  (0.22) 9.40  (0.17)
Day 1 Hour 6 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.49  (0.26) 9.38  (0.22) 9.50  (0.14) 9.47  (0.17) 9.60  (0.24) 9.48  (0.35) 9.25  (0.36) 9.18  (0.13) 9.38  (0.31) 9.40  (0.15)
Day 1 Hour 8 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.38  (0.22) 9.47  (0.29) 9.33  (0.23) 9.29  (0.18) 9.28  (0.12) 9.42  (0.28) 9.27  (0.33) 9.38  (0.21) 9.35  (0.10) 9.22  (0.12)
Day 1 Hour 10 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.53  (0.26) 9.62  (0.31) 9.50  (0.27) 9.40  (0.30) 9.38  (0.19) 9.36  (0.31) 9.28  (0.27) 9.50  (0.22) 9.45  (0.16) 9.42  (0.15)
Day 1 Hour 12 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.53  (0.28) 9.55  (0.27) 9.57  (0.31) 9.49  (0.31) 9.37  (0.34) 9.52  (0.26) 9.27  (0.34) 9.40  (0.24) 9.47  (0.19) 9.45  (0.19)
Day 2 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.46  (0.34) 9.55  (0.21) 9.23  (0.28) 9.39  (0.21) 9.37  (0.33) 9.46  (0.29) 9.23  (0.29) 8.55  (1.77) 9.05  (0.41) 9.28  (0.15)
Day 3 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.30  (0.61) 9.37  (0.29) 9.25  (0.39) 9.20  (0.34) 9.35  (0.14) 9.38  (0.41) 9.18  (0.17) 9.40  (0.24) 9.13  (0.51) 9.27  (0.18)
Day 4 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.49  (0.25) 9.38  (0.27) 9.37  (0.27) 9.18  (0.64) 9.27  (0.12) 9.40  (0.30) 9.13  (0.22) 9.23  (0.50) 8.88  (0.84) 9.18  (0.13)
Day 5 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.42  (0.36) 9.38  (0.21) 9.37  (0.25) 9.38  (0.24) 9.32  (0.25) 9.24  (0.26) 9.15  (0.18) 9.55  (0.17) 9.20  (0.15) 9.12  (0.19)
Day 6 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.56  (0.26) 9.45  (0.29) 9.45  (0.26) 9.51  (0.20) 9.35  (0.10) 9.36  (0.26) 9.18  (0.15) 9.35  (0.24) 9.32  (0.19) 9.23  (0.12)
Day 8 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.41  (0.31) 9.45  (0.20) 9.28  (0.23) 9.36  (0.44) 9.23  (0.10) 9.33  (0.40) 8.93  (0.28) 9.30  (0.22) 9.18  (0.29) 9.20  (0.37)
Day 11 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.32  (0.29) 9.38  (0.33) 9.07  (0.24) 9.39  (0.25) 9.30  (0.39) 9.19  (0.36) 8.70  (0.75) 9.30  (0.22) 9.13  (0.29) 9.18  (0.26)
Day 15 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.39  (0.26) 9.60  (0.17) 9.40  (0.32) 9.26  (0.21) 9.22  (0.19) 9.06  (0.35) 8.97  (0.18) 9.33  (0.22) 9.28  (0.33) 9.00  (0.36)
Day 22 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.35  (0.33) 9.53  (0.45) 9.18  (0.35) 9.33  (0.32) 9.22  (0.17) 9.14  (0.47) 8.90  (0.23) 9.48  (0.13) 9.18  (0.22) 9.08  (0.15)
Day 29 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.49  (0.32) 9.58  (0.22) 9.40  (0.26) 9.44  (0.37) 9.20  (0.27) 9.32  (0.28) 8.95  (0.19) 9.38  (0.13) 9.17  (0.21) 9.15  (0.23)
Day 36 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.40  (0.45) 9.33  (0.26) 9.23  (0.30) 9.00  (0.26) 9.07  (0.26) 9.25  (0.30) 9.18  (0.35) 9.00  (0.30)
Day 43 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.33  (0.39) 9.32  (0.21) 9.37  (0.31) 9.23  (0.36) 8.90  (0.26) 9.28  (0.33) 9.25  (0.25) 9.15  (0.33)
Day 50 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.35  (0.26) 9.30  (0.41) 9.03  (0.21) 9.40  (0.34) 8.98  (0.19) 9.33  (0.33) 9.43  (0.50) 9.07  (0.23)
Day 57 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
9.46  (0.30) 9.47  (0.36) 9.35  (0.29) 9.18  (0.49) 9.28  (0.17) 9.33  (0.29) 9.25  (0.27) 9.02  (0.21)
Day 64 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
9.22  (0.15) 9.28  (0.42) 8.90  (0.36) 9.25  (0.07) 9.18  (0.35)
Day 71 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
9.36  (0.18) 9.47  (0.47) 9.05  (0.36) 9.20  (0.14) 9.20  (0.14)
Day 78 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
9.30  (0.24) 9.31  (0.32) 9.07  (0.40) 9.20  (0.00) 9.12  (0.34)
Day 85 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
9.12  (0.08) 9.47  (0.35) 8.82  (0.31) 9.10  (0.28) 9.05  (0.26)
32.Secondary Outcome
Title Ionized Calcium Over Time
Hide Description [Not Specified]
Time Frame Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.
Arm/Group Title Placebo SC Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 10.0 mg/kg SC Placebo IV Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description:
Participants received a single subcutaneous (SC) injection of matching placebo.
Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.
Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.
Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.
Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.
Participants received a single intravenous (IV) injection of matching placebo.
Participants received a single intravenous injection of 1.0 mg/kg romosozumab.
Participants received a single intravenous injection of 5.0 mg/kg romosozumab
Overall Number of Participants Analyzed 14 6 6 9 6 9 6 4 6 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 1 Pre-dose Number Analyzed 13 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.02  (0.20) 4.95  (0.18) 5.02  (0.16) 5.01  (0.18) 4.88  (0.08) 5.07  (0.18) 4.85  (0.10) 5.30  (0.12) 5.18  (0.15) 5.27  (0.15)
Day 1 Hour 4 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.06  (0.20) 5.02  (0.17) 5.10  (0.13) 5.11  (0.24) 5.03  (0.10) 5.12  (0.32) 4.95  (0.08) 5.40  (0.14) 5.35  (0.18) 5.40  (0.09)
Day 1 Hour 6 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
4.97  (0.19) 4.93  (0.10) 4.98  (0.10) 4.97  (0.21) 4.93  (0.08) 5.06  (0.24) 4.87  (0.12) 5.10  (0.14) 5.28  (0.15) 5.30  (0.09)
Day 1 Hour 8 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
4.93  (0.14) 4.92  (0.15) 5.00  (0.11) 5.00  (0.21) 4.90  (0.06) 5.04  (0.27) 4.78  (0.12) 5.30  (0.08) 5.28  (0.17) 5.30  (0.09)
Day 1 Hour 10 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.06  (0.20) 5.00  (0.09) 5.05  (0.10) 5.11  (0.19) 4.95  (0.15) 5.07  (0.34) 4.88  (0.12) 5.30  (0.12) 5.32  (0.18) 5.38  (0.15)
Day 1 Hour 12 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.01  (0.18) 4.95  (0.08) 5.00  (0.15) 5.01  (0.20) 4.93  (0.16) 5.03  (0.30) 4.80  (0.11) 5.28  (0.22) 5.25  (0.10) 5.33  (0.08)
Day 2 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.04  (0.20) 5.03  (0.16) 4.92  (0.17) 5.03  (0.17) 4.98  (0.12) 5.04  (0.19) 4.88  (0.15) 5.28  (0.10) 5.08  (0.08) 5.18  (0.10)
Day 3 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.06  (0.19) 5.00  (0.13) 4.97  (0.14) 5.00  (0.14) 4.95  (0.08) 5.12  (0.20) 4.85  (0.05) 5.28  (0.13) 5.17  (0.12) 5.25  (0.14)
Day 4 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.05  (0.17) 4.97  (0.15) 4.85  (0.16) 5.03  (0.10) 4.87  (0.12) 5.11  (0.20) 4.82  (0.08) 5.23  (0.17) 5.20  (0.09) 5.17  (0.14)
Day 5 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.02  (0.18) 4.93  (0.10) 4.88  (0.25) 5.04  (0.12) 4.93  (0.12) 5.04  (0.19) 4.80  (0.06) 5.40  (0.14) 5.18  (0.12) 5.15  (0.14)
Day 6 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.02  (0.16) 4.91  (0.14) 4.97  (0.12) 5.06  (0.11) 4.88  (0.10) 5.02  (0.14) 4.80  (0.06) 5.23  (0.10) 5.23  (0.12) 5.05  (0.10)
Day 8 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.02  (0.17) 4.98  (0.08) 4.92  (0.10) 5.01  (0.24) 4.83  (0.10) 4.89  (0.18) 5.00  (0.14) 5.23  (0.17) 5.17  (0.12) 5.07  (0.19)
Day 11 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.01  (0.14) 5.05  (0.14) 4.93  (0.14) 5.06  (0.17) 4.90  (0.13) 4.92  (0.15) 5.00  (0.11) 5.23  (0.13) 5.20  (0.13) 5.10  (0.20)
Day 15 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.05  (0.16) 5.10  (0.19) 4.92  (0.12) 5.02  (0.16) 4.83  (0.12) 4.98  (0.19) 5.00  (0.06) 5.20  (0.22) 5.25  (0.12) 5.07  (0.12)
Day 22 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.03  (0.17) 5.05  (0.18) 4.82  (0.12) 4.92  (0.16) 4.85  (0.08) 5.08  (0.17) 5.05  (0.08) 5.18  (0.24) 5.12  (0.15) 5.05  (0.21)
Day 29 Number Analyzed 14 participants 6 participants 6 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.13  (0.17) 5.05  (0.08) 4.92  (0.17) 5.02  (0.20) 4.85  (0.08) 5.22  (0.12) 5.03  (0.16) 5.28  (0.17) 5.22  (0.10) 5.13  (0.20)
Day 36 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.16  (0.17) 4.96  (0.14) 5.07  (0.16) 5.11  (0.18) 4.96  (0.16) 5.28  (0.13) 5.18  (0.10) 5.18  (0.15)
Day 43 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.18  (0.23) 4.99  (0.15) 5.22  (0.13) 5.26  (0.21) 5.02  (0.08) 5.23  (0.17) 5.30  (0.13) 5.18  (0.12)
Day 50 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.21  (0.19) 5.19  (0.16) 5.20  (0.11) 5.16  (0.11) 5.00  (0.13) 5.28  (0.15) 5.32  (0.13) 5.15  (0.14)
Day 57 Number Analyzed 10 participants 0 participants 0 participants 9 participants 6 participants 9 participants 6 participants 4 participants 6 participants 6 participants
5.26  (0.14) 5.22  (0.14) 5.22  (0.10) 5.21  (0.15) 5.18  (0.13) 5.33  (0.17) 5.23  (0.08) 5.25  (0.15)
Day 64 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
5.18  (0.11) 5.22  (0.18) 5.13  (0.14) 5.15  (0.07) 5.17  (0.14)
Day 71 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
5.18  (0.08) 5.38  (0.16) 5.12  (0.18) 5.30  (0.28) 5.20  (0.13)
Day 78 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
5.28  (0.08) 5.30  (0.17) 5.15  (0.19) 5.15  (0.07) 5.27  (0.15)
Day 85 Number Analyzed 5 participants 0 participants 0 participants 0 participants 0 participants 9 participants 6 participants 2 participants 0 participants 6 participants
5.24  (0.11) 5.36  (0.13) 5.13  (0.22) 5.20  (0.14) 5.23  (0.14)
Time Frame Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
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 SC Placebo IV Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Hide Arm/Group Description Participants received a single subcutaneous (SC) injection of matching placebo. Participants received a single intravenous (IV) injection of matching placebo. Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab. Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab. Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab. Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab. Participants received a single intravenous injection of 1.0 mg/kg romosozumab. Participants received a single intravenous injection of 5.0 mg/kg romosozumab.
All-Cause Mortality
Placebo SC Placebo IV Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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 SC Placebo IV Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/4 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/9 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/9 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Hepatobiliary disorders                     
HEPATITIS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  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 SC Placebo IV Romosozumab 0.1 mg/kg SC Romosozumab 0.3 mg/kg SC Romosozumab 1.0 mg/kg SC Romosozumab 10.0 mg/kg SC Romosozumab 3.0 mg/kg SC Romosozumab 5.0 mg/kg SC Romosozumab 1.0 mg/kg IV Romosozumab 5.0 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/14 (64.29%)   2/4 (50.00%)   4/6 (66.67%)   4/6 (66.67%)   1/9 (11.11%)   5/6 (83.33%)   5/6 (83.33%)   6/9 (66.67%)   1/6 (16.67%)   2/6 (33.33%) 
Blood and lymphatic system disorders                     
ANAEMIA  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
IRON DEFICIENCY ANAEMIA  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
Endocrine disorders                     
BASEDOW'S DISEASE  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders                     
BLEPHARITIS  1  0/14 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
CONJUNCTIVITIS  1  0/14 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                     
ABDOMINAL PAIN  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
ABDOMINAL PAIN UPPER  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
APHTHOUS STOMATITIS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
CONSTIPATION  1  1/14 (7.14%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  1/6 (16.67%) 
DIARRHOEA  1  0/14 (0.00%)  0/4 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DRY MOUTH  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DYSPEPSIA  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
LIP DRY  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
NAUSEA  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
ORAL DISCOMFORT  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
VOMITING  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders                     
ASTHENIA  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
AXILLARY PAIN  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
CHEST PAIN  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE ERYTHEMA  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  4/6 (66.67%)  2/6 (33.33%)  2/9 (22.22%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE HAEMORRHAGE  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  0/6 (0.00%) 
INJECTION SITE REACTION  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
THIRST  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                     
CELLULITIS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
ESCHERICHIA URINARY TRACT INFECTION  1  0/14 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
GASTROENTERITIS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
HORDEOLUM  1  0/14 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
NASOPHARYNGITIS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
TINEA PEDIS  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  2/14 (14.29%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
URINARY TRACT INFECTION  1  0/14 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                     
DECREASED APPETITE  1  0/14 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                     
ARTHRALGIA  1  1/14 (7.14%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
BACK PAIN  1  1/14 (7.14%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCLE SPASMS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCULOSKELETAL DISCOMFORT  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
MUSCULOSKELETAL PAIN  1  2/14 (14.29%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
PAIN IN EXTREMITY  1  0/14 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders                     
DIZZINESS  1  1/14 (7.14%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
HEADACHE  1  3/14 (21.43%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/6 (0.00%) 
SOMNOLENCE  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders                     
BREAST TENDERNESS  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
COUGH  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
EPISTAXIS  1  0/14 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
PHARYNGOLARYNGEAL PAIN  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                     
DERMATITIS  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
DERMATITIS CONTACT  1  1/14 (7.14%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders                     
HOT FLUSH  1  0/14 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
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: NCT01059435     History of Changes
Other Study ID Numbers: 20060220
First Submitted: January 28, 2010
First Posted: February 1, 2010
Results First Submitted: April 10, 2019
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019