Text Size

A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00890981
First received: April 23, 2009
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
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
Intervention: Procedure: HR-pQCT, DXA and BTM measurements

  Participant Flow
  Hide Participant Flow

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 Subjects who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Previous Denosumab 60 mg Q6M Treatment Group Subjects 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 60 mg Q6M Treatment Group  
STARTED     39     40  
COMPLETED     39     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Previous Placebo Treatment Group Subjects who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Previous Denosumab 60 mg Q6M Treatment Group Subjects 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 60 mg Q6M Treatment Group     Total  
Number of Participants  
[units: participants]
 		  39     40     79  
Age  
[units: Participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     21     33  
>=65 years     17     19     36  
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]
 		     
White or Caucasian     39     40     79  
Months since last SC dose of 20050179  
[units: Months]
Mean ± Standard Deviation 		  32.1  ± 2.5     32.2  ± 2.7     32.1  ± 2.6  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Percent Change From the Parent Study Baseline in Total BMD at the Distal Radius by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 2

3.  Secondary:   Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 3

4.  Secondary:   Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 4

5.  Secondary:   Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 5

6.  Secondary:   Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 7

8.  Secondary:   Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT   [ Time Frame: Day 1 ]
  Show Outcome Measure 8

9.  Secondary:   Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA   [ Time Frame: Day 1 ]
  Show Outcome Measure 9

10.  Secondary:   Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA   [ Time Frame: Day 1 ]
  Show Outcome Measure 10

11.  Secondary:   Percent Change of Total Radius BMD From the Parent Study Baseline by DXA   [ Time Frame: Day 1 ]
  Show Outcome Measure 11

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Show More Information