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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00493623

Purpose

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

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:

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

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 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

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, 13305

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:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00493623 History of Changes
Other Study ID Numbers:	ML19360
Study First Received:	June 27, 2007
Last Updated:	May 18, 2011
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 February 09, 2012