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

NCT01495000 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-02-07

Study results available
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Summary

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

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

denosumab

60mg subcutaneous injection, single dose

DRUG

placebo

placebo 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
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • India

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 NCT01495000 on ClinicalTrials.gov