Back to resultsA Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
100 mg AMG 162
60 mg AMG 162
14 mg AMG 162
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, Japanese
Eligibility Criteria
Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
100 mg AMG 162
60 mg AMG 162
Placebo
14 mg AMG 162
Arm Description
Outcomes
Primary Outcome Measures
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00306189
Brief Title
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
Official Title
Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 mg AMG 162
Arm Type
Active Comparator
Arm Title
60 mg AMG 162
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
14 mg AMG 162
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
100 mg AMG 162
Intervention Description
100 mg AMG 162 (denosumab) SC every 6 months
Intervention Type
Drug
Intervention Name(s)
60 mg AMG 162
Intervention Description
60 mg AMG 162 (denosumab) SC every 6 months
Intervention Type
Drug
Intervention Name(s)
14 mg AMG 162
Intervention Description
14 mg AMG 162 (denosumab) SC every 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo SC every 6 months
Primary Outcome Measure Information:
Title
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Description
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame
12 months
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21927920
Citation
Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. Epub 2011 Sep 17.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_49_AMG_162_20050172.pdf
Description
To access clinical trial results information click on this link
Learn more about this trial
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
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