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A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

NCT00129623 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-01-11

Study results available
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Summary

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Conditions

  • Post-Menopausal Osteopenia

Interventions

DRUG

Placebo

po monthly for 1 year

DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 1 year

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

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 NCT00129623 on ClinicalTrials.gov