A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: 100 mg AMG 162 Drug: 60 mg AMG 162 Drug: 14 mg AMG 162 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 - |
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
| Enrollment: | 212 |
| Study Start Date: | January 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 100 mg AMG 162 |
Drug: 100 mg AMG 162
100 mg AMG 162 (denosumab) SC every 6 months
|
| Active Comparator: 60 mg AMG 162 |
Drug: 60 mg AMG 162
60 mg AMG 162 (denosumab) SC every 6 months
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo SC every 6 months
|
| Active Comparator: 14 mg AMG 162 |
Drug: 14 mg AMG 162
14 mg AMG 162 (denosumab) SC every 6 months
|
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00306189 History of Changes |
| Other Study ID Numbers: | 20050172, NOT APPRICABLE |
| Study First Received: | March 21, 2006 |
| Results First Received: | December 22, 2009 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Amgen:
|
RANKL RANK denosumab AMG 162 |
osteoporosis bone turnover bone mineral density Japanese |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013