Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: AMG 162; Drug: Placebo

• Registration Number: NCT00091793
• Lead Sponsor: Amgen

Brief Summary

This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-09-17
• Study First Submitted QC: 2004-09-20
• Study First Posted: 2004-09-21
• Primary Completion: 2009-02
• Study Completion: 2009-03
• 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: 2010-01-26
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 332

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 162	AMG 162	60 mg/mL denosumab given day 1, month 6, month 12 and month 18
Placebo	Placebo	Placebo given day 1, month 6, month 12 and month 18

Primary Outcome Measures

Name	Time	Method
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	24 Months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Secondary Outcome Measures

Name	Time	Method
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	24 Months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24	24 Months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).