CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 486 enrolled
Drug / intervention
Denosumab +3 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/NCT02014467
NCT02014467Phase 3Completed
CompareCT.gov

A Twelve-Month Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Chinese Postmenopausal Women With Osteoporosis at Increased Risk of Fracture

GlaxoSmithKline·interventional·Posted Dec 18, 2013·Updated Oct 31, 2016

In Brief

A Phase 3 clinical trial evaluating Denosumab, Placebo, and 2 other interventions for Osteoporosis, Postmenopausal. Completed, enrolled 486 participants across 8 sites.

Detailed Summary

This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 18, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.5 years ago

Interventions

Denosumabdrug

Injection

Placebodrug

Injection

Elemental Calciumdietary

Oral, at least 600 mg

Vitamin Ddietary

Oral, at least 400 IU