At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 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, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women With Low Bone Mass
In Brief
A Phase 1 clinical trial evaluating Romosozumab and Placebo for Postmenopausal and Osteopenia. Completed, enrolled 48 participants.
Detailed Summary
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal, Osteopenia
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
Primary CompletionDec 2008
First PostedApr 2013
TodayJul 2026
First PostedApr 8, 2013
Enrollment StartNov 14, 2007
Primary CompletionDec 2, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.2 years ago
Interventions
Romosozumabdrug
Administered by subcutaneous injection
Placebodrug
Administered by subcutaneous injection