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A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

NCT00936897 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 833

Last updated 2013-02-11

Study results available
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Summary

This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Ibandronate

Ibandronate 150mg PO QM (tablet)

DRUG

Denosumab

denosumab 60mg SC Q6M (pre-filled syringe)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-11-30
Completion
2012-01-31

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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 NCT00936897 on ClinicalTrials.gov