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DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

NCT00048074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1395

Last updated 2016-02-03

Study results available
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Summary

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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]

2mg iv every 2 months

DRUG

ibandronate [Bonviva/Boniva]

2.5mg po daily

DRUG

ibandronate [Bonviva/Boniva]

3mg iv every 3 months

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
2002-06-30
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Norway
  • Poland
  • South Africa
  • 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 NCT00048074 on ClinicalTrials.gov