CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 419 enrolled
Drug / intervention
Placebo to Romosozumab +6 moredrug
Likely dose
Teriparatide 20 μgfrom 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/NCT00896532
NCT00896532Phase 2Completed
CompareCT.gov

A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Amgen·interventional·Posted May 11, 2009·Updated Sep 22, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo to Romosozumab, Alendronate, and 5 other interventions for Low Bone Mineral Density and Postmenopausal Osteoporosis. Completed, enrolled 419 participants.

Detailed Summary

The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Bone Mineral Density, Postmenopausal Osteoporosis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2009
Enrollment StartJun 3, 2009
Primary CompletionFeb 21, 2011
Study CompletionFeb 18, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.1 years ago

Interventions

Placebo to Romosozumabdrug

Administered by subcutaneous injection QM or Q3M.

Alendronatedrug

Administered orally once a week

Teriparatidedrug

Teriparatide 20 μg administered by subcutaneous injection once a day

Romosozumabdrug

Administered by subcutaneous injection

Denosumabdrug

Denosumab 60 mg administered by subcutaneous injection Q6M

Placebo to Denosumabdrug

Administered by subcutaneous injection Q6M

Zoledronic aciddrug

Zoledronic acid 5 mg administered intravenously