A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: 14 mg AMG 162; Drug: 100 mg AMG 162; Drug: 60 mg AMG 162; Drug: Placebo

• Registration Number: NCT00306189
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-23
• Primary Completion: 2007-06
• Study Completion: 2007-11
• Disposition First Submitted: 2009-11-23
• Disposition First Submitted QC: 2009-11-23
• Disposition First Posted: 2009-11-25
• Results First Submitted: 2009-12-22
• Results First Submitted QC: 2009-12-22
• Results First Posted: 2010-01-27
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14 mg AMG 162	14 mg AMG 162	-
100 mg AMG 162	100 mg AMG 162	-
60 mg AMG 162	60 mg AMG 162	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12	12 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.