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BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.

NCT00493623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2016-03-02

No results posted yet for this study

Summary

This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Conditions

Interventions

DRUG

Placebo

Placebo i.v. single dose

DRUG

ibandronate [Bonviva/Boniva]

3mg i.v. single dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
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 NCT00493623 on ClinicalTrials.gov