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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493623
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : March 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
3mg i.v. single dose
Placebo Comparator: 2 Drug: Placebo
Placebo i.v. single dose

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage of patients with >=50% diminution of pain between day 0 and 7 [ Time Frame: Day 7 ]
  2. Pain control [ Time Frame: Day 7 and 1 month ]
  3. Analgesic medication [ Time Frame: 1 month ]
  4. Hospitalization [ Time Frame: 1 month ]
  5. AEs and laboratory parameters [ Time Frame: Throughout study ]

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493623

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00493623     History of Changes
Other Study ID Numbers: ML19360
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016

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