Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Phase 3CompletedNCT00091793

Amgen332 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

332

Conditions

Postmenopausal Osteoporosis

Interventions

60 mg/mL denosumab given day 1, month 6, month 12 and month 18

Placebo given at day 1, month 6, month 12 and month 18

Eligibility

Sex: FEMALEMax age: 90 Years

Medical Language ↔ Plain English

Eligibility Criteria \- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Outcomes

Primary Outcomes

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 24 Months

Secondary Outcomes

Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 24 Months

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 24 Months

Trochanter Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 24 months

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 24 months

Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 24 months

Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

Time frame: 24 months

Data from ClinicalTrials.gov

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