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Denosumab China Phase III Study

NCT02014467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2016-10-31

Study results available
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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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

Denosumab

Injection

DRUG

Placebo

Injection

DIETARY_SUPPLEMENT

Elemental Calcium

Oral, at least 600 mg

DIETARY_SUPPLEMENT

Vitamin D

Oral, at least 400 IU

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014467 on ClinicalTrials.gov