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A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

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: NCT00890981
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : July 28, 2011
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Low Bone Mass
Low Bone Mineral Density
Osteoporosis
Postmenopausal Osteoporosis
Interventions Procedure: high-resolution peripheral quantitative computed tomography (HR-pQCT)
Procedure: Dual energy X-ray absorptiometry (DXA)
Biological: Denosumab
Drug: Placebo
Enrollment 79
Recruitment Details The first subject enrolled on 14-JUL-2009. The last subject enrolled on 12-MAY-2010
Pre-assignment Details  
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study. Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Period Title: Overall Study
Started 39 40
Completed 39 40
Not Completed 0 0
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group Total
Hide Arm/Group Description Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. Total of all reporting groups
Overall Number of Baseline Participants 39 40 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 40 participants 79 participants
63.9  (5.8) 63.4  (6.5) 63.7  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 40 participants 79 participants
Female
39
 100.0%
40
 100.0%
79
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 40 participants 79 participants
39 40 79
Months since last dose in 20050179  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 39 participants 40 participants 79 participants
32.1  (2.5) 32.2  (2.7) 32.1  (2.6)
1.Primary Outcome
Title Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-5.5
(-8.3 to -2.8)
-1.8
(-4.8 to 1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0766
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.7
Confidence Interval 95%
-0.4 to 7.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-1.2
(-2.6 to 0.2)
0.3
(-1.2 to 1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1648
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Confidence Interval 95%
-0.6 to 3.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-1.0
(-1.7 to -0.3)
-0.0
(-0.8 to 0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Confidence Interval 95%
0.1 to 1.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
5.1
(2.3 to 8.0)
5.9
(2.8 to 9.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6560
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval 95%
-2.5 to 4.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-6.4
(-7.8 to -5.1)
-4.6
(-5.9 to -3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0594
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.8
Confidence Interval 95%
-0.1 to 3.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-1.6
(-2.8 to -0.4)
1.0
(-0.2 to 2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.6
Confidence Interval 95%
0.9 to 4.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-1.0
(-1.7 to -0.3)
-0.6
(-1.4 to 0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2897
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval 95%
-0.4 to 1.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT
Hide Description Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
2.9
(1.0 to 4.9)
6.8
(4.9 to 8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.9
Confidence Interval 95%
1.1 to 6.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA
Hide Description Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-2.0
(-3.3 to -0.8)
0.0
(-1.2 to 1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1
Confidence Interval 95%
0.4 to 3.8
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA
Hide Description Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-3.5
(-4.9 to -2.2)
-1.9
(-3.3 to -0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0911
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.6
Confidence Interval 95%
-0.3 to 3.5
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change of Total Radius BMD From the Parent Study Baseline by DXA
Hide Description Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
Time Frame Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-3.0
(-4.0 to -2.0)
-0.9
(-1.9 to 0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1
Confidence Interval 95%
0.7 to 3.5
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Actual Value of Serum Type I C-telopeptide
Hide Description Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ng/mL
0.6
(0.5 to 0.6)
0.7
(0.6 to 0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0591
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Denosumab to Placebo
Estimated Value 1.1
Confidence Interval 95%
1.0 to 1.3
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Actual Value of Procollagen Type 1 N-terminal Peptide
Hide Description Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with observed data.
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description:
Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: µg/L
49.8
(45.6 to 54.3)
58.9
(54.1 to 64.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Previous Placebo Treatment Group, Previous Denosumab Treatment Group
Comments ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0079
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Denosumab to Placebo
Estimated Value 1.2
Confidence Interval 95%
1.0 to 1.3
Estimation Comments [Not Specified]
Time Frame AEs (serious only) were collected after informed consent and through 30 days after the study procedures, maximum time on study was 44 days.
Adverse Event Reporting Description Only Serious Adverse Events were collected for this study.
 
Arm/Group Title Previous Placebo Treatment Group Previous Denosumab Treatment Group
Hide Arm/Group Description Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
All-Cause Mortality
Previous Placebo Treatment Group Previous Denosumab Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Previous Placebo Treatment Group Previous Denosumab Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Previous Placebo Treatment Group Previous Denosumab Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Publications:
concept.747 Treatment/discontinuation on wrist.Journal-004521;
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00890981     History of Changes
Other Study ID Numbers: 20080747
First Submitted: April 23, 2009
First Posted: April 30, 2009
Results First Submitted: June 30, 2011
Results First Posted: July 28, 2011
Last Update Posted: April 2, 2014