CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 332 enrolled
Drug / intervention
AMG 162 +1 moredrug
Likely dose
AMG 162 (denosumab) 60 mg subcutaneously given day 1, month 6, month 12, and month 18AI-extracted
Key inclusion· 2
  • ✓Postmenopausal women
  • ✓Lumbar spine bone mineral density T-score between -2.5 and -1.0 (osteopenia)
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00091793
NCT00091793Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Amgen·interventional·Posted Sep 21, 2004·Updated Dec 31, 2010

In Brief

A Phase 3 clinical trial evaluating AMG 162 and Placebo for Postmenopausal Osteoporosis. Completed, enrolled 332 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2004
Enrollment StartAug 1, 2004
Primary CompletionFeb 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 21.8 years ago

Interventions

AMG 162drug

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

Placebodrug

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