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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00890981
First received: April 23, 2009
Last updated: March 5, 2014
Last verified: March 2014
Results First Received: June 30, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject enrolled on 14-JUL-2009. The last subject enrolled on 12-MAY-2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Previous Placebo Treatment Group Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.
Previous Denosumab Treatment Group Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.

Participant Flow:   Overall Study
    Previous Placebo Treatment Group     Previous Denosumab Treatment Group  
STARTED     39     40  
COMPLETED     39     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Previous Placebo Treatment Group Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Previous Denosumab Treatment Group Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Total Total of all reporting groups

Baseline Measures
    Previous Placebo Treatment Group     Previous Denosumab Treatment Group     Total  
Number of Participants  
[units: participants]
  39     40     79  
Age  
[units: Years]
Mean ± Standard Deviation
  63.9  ± 5.8     63.4  ± 6.5     63.7  ± 6.1  
Gender  
[units: Participants]
     
Female     39     40     79  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
  39     40     79  
Months since last dose in 20050179  
[units: Months]
Mean ± Standard Deviation
  32.1  ± 2.5     32.2  ± 2.7     32.1  ± 2.6  



  Outcome Measures
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1.  Primary:   Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT   [ 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. ]

2.  Secondary:   Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT   [ 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. ]

3.  Secondary:   Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT   [ 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. ]

4.  Secondary:   Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT   [ 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. ]

5.  Secondary:   Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT   [ 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. ]

6.  Secondary:   Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT   [ 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. ]

7.  Secondary:   Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT   [ 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. ]

8.  Secondary:   Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT   [ 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. ]

9.  Secondary:   Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA   [ 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. ]

10.  Secondary:   Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA   [ 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. ]

11.  Secondary:   Percent Change of Total Radius BMD From the Parent Study Baseline by DXA   [ 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. ]

12.  Secondary:   Actual Value of Serum Type I C-telopeptide   [ Time Frame: Day 1 ]

13.  Secondary:   Actual Value of Procollagen Type 1 N-terminal Peptide   [ Time Frame: Day 1 ]


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  Limitations and Caveats


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