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

NCT00545207 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-01-26

No results posted yet for this study

Summary

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Conditions

  • Post-Menopausal Osteopenia

Interventions

DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 2 years

DRUG

Placebo

po monthly for 2 years

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

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

Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • France

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 NCT00545207 on ClinicalTrials.gov