At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 31 enrolled
Drug / intervention
Romosozumab +1 moredrug
Likely dose
Not stated in 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.
A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Postmenopausal Japanese Women
In Brief
A Phase 1 clinical trial evaluating Romosozumab and Placebo for Osteopenia. Completed, enrolled 31 participants.
Detailed Summary
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteopenia
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionNov 2010
TodayJul 2026
First PostedApr 9, 2010
Enrollment StartMay 3, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.2 years ago
Interventions
Romosozumabdrug
Administered by subcutaneous injection
Placebodrug
Administered by subcutaneous injection