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Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

NCT01732770 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2020-03-10

Study results available
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Summary

This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

Conditions

  • Post Menopausal Osteoporosis

Interventions

BIOLOGICAL

Denosumab

Denosumab 60 mg administered by subcutaneous injection once every 6 months.

DRUG

Zoledronic Acid

Zoledronic acid 5 mg administered by intravenous infusion once a year

DRUG

Placebo to Denosumab

Administered by subcutaneous injection once every 6 months

DRUG

Placebo to Zoledronic Acid

Administered by intravenous infusion once a year

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-07
Primary Completion
2015-01-07
Completion
2015-01-07

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Poland
  • Spain

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 NCT01732770 on ClinicalTrials.gov