Phase 3 N=332 Randomized Quadruple-blind Prevention

Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Postmenopausal Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00091793 ↗

Enrolled (actual)

332

Serious AEs

8.2%

Results posted

Jan 2010

Primary outcome: Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 — 6.5; -.6 Percent Change from Baseline — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AMG 162 (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Amgen
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	6.5; -.6	<0.0001 sig
SECONDARY Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	3.4; -1.1	—
SECONDARY Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24	2.8; -.9	—
SECONDARY Trochanter Bone Mineral Density Percent Change From Baseline at Month 24	5.2; -.8	—
SECONDARY Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24	1.4; -2.1	—
SECONDARY Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24	2.4; -1.4	—
SECONDARY Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	8.7; -.7	—
SECONDARY Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	.3; -1.4	—
SECONDARY Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	.8; -1.9	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00091793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.