CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 212 enrolled
Drug / intervention
100 mg AMG 162 +3 moredrug
Likely dose
100 mg AMG 162from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00306189
NCT00306189Phase 2Completed
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Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -

Amgen·interventional·Posted Mar 23, 2006·Updated Jun 20, 2013

In Brief

A Phase 2 clinical trial evaluating 100 mg AMG 162, 60 mg AMG 162, and 2 other interventions for Osteoporosis. Completed, enrolled 212 participants.

Detailed Summary

The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2006
Enrollment StartJan 1, 2006
Primary CompletionJun 1, 2007
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.3 years ago

Interventions

100 mg AMG 162drug

100 mg AMG 162 (denosumab) SC every 6 months

60 mg AMG 162drug

60 mg AMG 162 (denosumab) SC every 6 months

14 mg AMG 162drug

14 mg AMG 162 (denosumab) SC every 6 months

Placebodrug

Placebo SC every 6 months