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A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

NCT00081653 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 719

Last updated 2017-07-14

Study results available
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Summary

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

  • Post-Menopausal Osteoporosis

Interventions

DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 3 years

DRUG

ibandronate [Bonviva/Boniva]

100mg po monthly for 3 years

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-11-30
Completion
2008-05-31

Countries

  • United States
  • Belgium
  • Brazil
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Norway
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00081653 on ClinicalTrials.gov