CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
Placebo +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/NCT03822078
NCT03822078Phase 1Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 162 Administered Subcutaneously to Japanese Postmenopausal Women

Amgen·interventional·Posted Jan 30, 2019·Updated Jul 24, 2019

In Brief

A Phase 1 clinical trial evaluating Placebo and Denosumab for Osteoporosis. Completed, enrolled 45 participants.

Detailed Summary

The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

Study Details

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

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2019
Enrollment StartSep 30, 2003
Primary CompletionDec 24, 2004
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.4 years ago

Interventions

Placebodrug

Administered by subcutaneous injection

Denosumabbiological

Administered by subcutaneous injection