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

March 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix En Provence, France, 13616
      • Amiens, France, 80054
      • Angers, France, 49033
      • Bonneville, France, 74136
      • Bordeaux, France, 33076
      • Caen, France, 14033
      • Cannes, France, 06401
      • Clermont-ferrand, France, 63003
      • Echirolles, France, 38434
      • Lille, France, 59037
      • Lomme, France, 59462
      • Marseille, France, 13285
      • Marseille, France, 13385
      • Montpellier, France, 34295
      • Mulhouse, France, 68070
      • Nantes, France, 44035
      • Nice, France, 06202
      • Orleans, France, 45000
      • Paris, France, 75651
      • Paris, France, 75475
      • Paris, France, 75674
      • Paris, France, 75571
      • Paris, France, 75181
      • Rennes, France, 35203
      • Rouen, France, 76031
      • Saint-priest En Jarez, France, 42277
      • Toulouse, France, 31059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Placebo i.v. single dose
EXPERIMENTAL: 1
Drug: ibandronate [Bonviva/Boniva]
3mg i.v. single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
Time Frame: Day 7
Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs and laboratory parameters
Time Frame: Throughout study
Throughout study
Percentage of patients with >=50% diminution of pain between day 0 and 7
Time Frame: Day 7
Day 7
Pain control
Time Frame: Day 7 and 1 month
Day 7 and 1 month
Analgesic medication
Time Frame: 1 month
1 month
Hospitalization
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (ESTIMATE)

June 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19360

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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