CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 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.

Search/NCT01059435
NCT01059435Phase 1Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women

Amgen·interventional·Posted Feb 1, 2010·Updated Jul 5, 2019

In Brief

A Phase 1 clinical trial evaluating Romosozumab and Placebo for Osteopenia. Completed, enrolled 74 participants.

Detailed Summary

The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.

Study Details

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

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2010
Enrollment StartDec 13, 2006
Primary CompletionJul 6, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.4 years ago

Interventions

Romosozumabdrug

Administered subcutaneously or intravenously

Placebodrug

Administered subcutaneously or intravenously