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MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

NCT00048061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1609

Last updated 2018-03-29

Study results available
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Summary

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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]

2.5mg po daily

DRUG

Ibandronate [Bonviva/Boniva]

100mg po monthly on a single day

DRUG

Ibandronate [Bonviva/Boniva]

100mg po monthly over 2 consecutive days

DRUG

Ibandronate [Bonviva/Boniva]

150mg po monthly

DIETARY_SUPPLEMENT

Calcium

500 mg/day

DIETARY_SUPPLEMENT

Vitamin D

400 IU/day

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
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Norway
  • Poland
  • Romania
  • South Africa
  • Spain
  • Switzerland
  • 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 NCT00048061 on ClinicalTrials.gov