A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
Primary Purpose
Low Bone Mass, Low Bone Mineral Density, Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
high-resolution peripheral quantitative computed tomography (HR-pQCT)
Dual energy X-ray absorptiometry (DXA)
Denosumab
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Low Bone Mass
Eligibility Criteria
Inclusion Criteria:
- Ambulatory, postmenopausal women
- Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
- At least 12 months have elapsed since their end of 20050179 study visit
- Provide signed informed consent
Exclusion Criteria:
- Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
- Subjects who were randomized to the alendronate arm during the 20050179 study
- Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
- Hyperthyroidism
- Hyperparathyroidism
- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
- Other diseases which affect bone metabolism
- Self-reported alcohol or drug abuse within the previous 12 months
- Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
- Received any investigational product other than denosumab in two years before the screening visit.
- Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
- Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
- Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
Outcomes
Primary Outcome Measures
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
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.
Secondary Outcome Measures
Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT
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.
Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT
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.
Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT
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.
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT
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.
Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT
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.
Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT
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.
Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT
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.
Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA
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.
Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA
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.
Percent Change of Total Radius BMD From the Parent Study Baseline by DXA
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.
Actual Value of Serum Type I C-telopeptide
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).
Actual Value of Procollagen Type 1 N-terminal Peptide
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00890981
Brief Title
A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
Official Title
A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
Intervention Type
Procedure
Intervention Name(s)
high-resolution peripheral quantitative computed tomography (HR-pQCT)
Intervention Description
Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.
Intervention Type
Procedure
Intervention Name(s)
Dual energy X-ray absorptiometry (DXA)
Intervention Description
Bone densitometry assessments of the forearm by DXA on day 1.
Intervention Type
Biological
Intervention Name(s)
Denosumab
Intervention Description
Denosumab 60 mg subcutaneously every 6 months in the previous study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to denosumab subcutaneously every 6 months in the previous study
Primary Outcome Measure Information:
Title
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
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.
Secondary Outcome Measure Information:
Title
Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT
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.
Title
Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT
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.
Title
Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT
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.
Title
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT
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.
Title
Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT
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.
Title
Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT
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.
Title
Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT
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.
Title
Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA
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.
Title
Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA
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.
Title
Percent Change of Total Radius BMD From the Parent Study Baseline by DXA
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.
Title
Actual Value of Serum Type I C-telopeptide
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
Title
Actual Value of Procollagen Type 1 N-terminal Peptide
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory, postmenopausal women
Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
At least 12 months have elapsed since their end of 20050179 study visit
Provide signed informed consent
Exclusion Criteria:
Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
Subjects who were randomized to the alendronate arm during the 20050179 study
Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
Hyperthyroidism
Hyperparathyroidism
Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
Other diseases which affect bone metabolism
Self-reported alcohol or drug abuse within the previous 12 months
Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Received any investigational product other than denosumab in two years before the screening visit.
Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
Citation
concept.747 Treatment/discontinuation on wrist.Journal-004521;
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
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