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Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

NCT00091793 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2010-12-31

Study results available
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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.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

AMG 162

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2009-02-28
Completion
2009-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00091793 on ClinicalTrials.gov