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

NCT ID: NCT00493623

Last Updated: 2016-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

3mg i.v. single dose

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo i.v. single dose

Interventions

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Placebo

Placebo i.v. single dose

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

3mg i.v. single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* postmenopausal women or men \>30 years of age;
* osteoporosis;
* vertebral osteoporotic fracture in past 4 weeks;
* fracture-related pain requiring analgesic treatment.

Exclusion Criteria

* non-menopausal women;
* current treatment with another bisphosphonate;
* current treatment with class III analgesics.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Aix-en-Provence, , France

Site Status

Amiens, , France

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Angers, , France

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Bonneville, , France

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Bordeaux, , France

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Caen, , France

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Cannes, , France

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Clermont-Ferrand, , France

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Échirolles, , France

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Lille, , France

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Lomme, , France

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Marseille, , France

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Marseille, , France

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Montpellier, , France

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Mulhouse, , France

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Nantes, , France

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Nice, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Rennes, , France

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Rouen, , France

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Saint-Priest-en-Jarez, , France

Site Status

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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ML19360

Identifier Type: -

Identifier Source: org_study_id

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