A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: 100 mg AMG 162 (Drug); 60 mg AMG 162 (Drug); 14 mg AMG 162 (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Eligibility
Minimum age: N/A.
Maximum age: 80 Years.
Gender(s): Female.
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.
Locations and Contacts
Additional Information
AmgenTrials clinical trials website Notice regarding posted summaries of trial results To access clinical trial results information click on this link
Starting date: January 2006
Last updated: June 13, 2013
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