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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00493623
First received: June 27, 2007
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This 2 arm study will assess the efficacy and safety of intravenous Bonviva in p atients 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.


Condition Intervention Phase
Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with >=50% diminution of pain between day 0 and 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Pain control [ Time Frame: Day 7 and 1 month ] [ Designated as safety issue: No ]
  • Analgesic medication [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Hospitalization [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
3mg i.v. single dose
Placebo Comparator: 2 Drug: Placebo
Placebo i.v. single dose

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493623

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, 75674
Paris, France, 75181
Paris, France, 75571
Paris, France, 75651
Paris, France, 75475
Rennes, France, 35203
Rouen, France, 76031
Saint-priest En Jarez, France, 42277
Toulouse, France, 31059
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00493623     History of Changes
Other Study ID Numbers: ML19360
Study First Received: June 27, 2007
Last Updated: July 7, 2014
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Osteoporosis
Osteoporotic Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014