MedTrace Logo

A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

NCT01457950 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2014-05-07

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

denosumab

double-blind phase: 60mg subcutaneous injection, single dose

DRUG

placebo

double-blind phase: placebo subcutaneous injection, single dose

DRUG

open-label denosumab

open-label phase: 60mg subcutaneous injection, single dose

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
2011-11-30
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • South Korea

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 NCT01457950 on ClinicalTrials.gov