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A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00887965
First received: April 23, 2009
Last updated: October 23, 2013
Last verified: October 2013
Results First Received: June 30, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Low Bone Mass
Low Bone Mineral Density
Osteoporosis
Postmenopausal Osteoporosis
Intervention: Drug: Previous denosumab

  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
First subject enrolled on 02-JUN-09. Last subject enrolled on 28-APR-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 Denosumab Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.

Participant Flow:   Overall Study
    Previous Denosumab  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     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 Denosumab Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.

Baseline Measures
    Previous Denosumab  
Number of Participants  
[units: participants]
  15  
Age  
[units: Years]
Mean ± Standard Deviation
  62.1  ± 5.9  
Gender  
[units: Participants]
 
Female     15  
Male     0  
Ethnic group: White or Caucasian  
[units: Participants]
  15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Normal/Abnormal Bone Histology   [ Time Frame: 25-34 days post-Day 1 ]

2.  Secondary:   Bone Histomorphometry: Cancellous Bone Volume   [ Time Frame: 25-34 days post-Day 1 ]

3.  Secondary:   Bone Histomorphometry: Trabecular Number   [ Time Frame: 25-34 days post-Day 1 ]

4.  Secondary:   Bone Histomorphometry: Trabecular Separation   [ Time Frame: 25-34 days post-Day 1 ]

5.  Secondary:   Bone Histomorphometry: Trabecular Thickness   [ Time Frame: 25-34 days post-Day 1 ]

6.  Secondary:   Bone Histomorphometry: Cortical Width   [ Time Frame: 25-34 days post-Day 1 ]

7.  Secondary:   Bone Histomorphometry: Surface Density   [ Time Frame: 25-34 days post-Day 1 ]

8.  Secondary:   Bone Histomorphometry: Osteoblast - Osteoid Interface   [ Time Frame: 25-34 days post-Day 1 ]

9.  Secondary:   Bone Histomorphometry: Osteoid Surface   [ Time Frame: 25-34 days post-Day 1 ]

10.  Secondary:   Bone Histomorphometry: Osteoid Width   [ Time Frame: 25-34 days post-Day 1 ]

11.  Secondary:   Bone Histomorphometry: Wall Thickness   [ Time Frame: 25-34 days post-Day 1 ]

12.  Secondary:   Bone Histomorphometry: Eroded Surface/Bone Surface   [ Time Frame: 25-34 days post-Day 1 ]

13.  Secondary:   Bone Histomorphometry: Osteoclast Number - Length Based   [ Time Frame: 25-34 days post-Day 1 ]

14.  Secondary:   Bone Histomorphometry: Osteoclast Number - Surface Based   [ Time Frame: 25-34 days post-Day 1 ]

15.  Secondary:   Bone Histomorphometry: Single-label Surface   [ Time Frame: 25-34 days post-Day 1 ]

16.  Secondary:   Bone Histomorphometry: Double-label Surface   [ Time Frame: 25-34 days post-Day 1 ]

17.  Secondary:   Bone Histomorphometry: Total Mineralizing Surface   [ Time Frame: 25-34 days post-Day 1 ]

18.  Secondary:   Bone Histomorphometry: Mineral Apposition Rate   [ Time Frame: 25-34 days post-Day 1 ]

19.  Secondary:   Bone Histomorphometry: Adjusted Mineral Apposition Rate   [ Time Frame: 25-34 days post-Day 1 ]

20.  Secondary:   Bone Histomorphometry: Bone Formation Rate - Surface Based   [ Time Frame: 25-34 days post-Day 1 ]

21.  Secondary:   Bone Histomorphometry: Bone Formation Rate - Volume Based   [ Time Frame: 25-34 days post-Day 1 ]

22.  Secondary:   Bone Histomorphometry: Formation Period   [ Time Frame: 25-34 days post-Day 1 ]

23.  Secondary:   Bone Histomorphometry: Activation Frequency   [ Time Frame: 25-34 days post-Day 1 ]

24.  Secondary:   Bone Histomorphometry: Osteoid Volume   [ Time Frame: 25-34 days post-Day 1 ]

25.  Secondary:   Bone Histomorphometry: Mineralization Lag Time   [ Time Frame: 25-34 days post-Day 1 ]

26.  Secondary:   C-Telopeptide (CTX-1)   [ Time Frame: Day 3 or Day 20 ]

27.  Secondary:   Procollagen Type 1 N-terminal Peptide (P1NP)   [ Time Frame: Day 3 or Day 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00887965     History of Changes
Other Study ID Numbers: 20080287
Study First Received: April 23, 2009
Results First Received: June 30, 2011
Last Updated: October 23, 2013
Health Authority: Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)
Argentina: Ministry of Health
Canada: Health Canada
United States: Food and Drug Administration