BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: ibandronate [Bonviva/Boniva] (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Overall contact:
Please reference Study ID Number: RLI_ML19360, Phone: 973-235-5000
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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).
Secondary outcome: Percentage of patients with >=50% diminution of pain between day 0 and 7Pain control Analgesic medication Hospitalization AEs and laboratory parameters
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Please reference Study ID Number: RLI_ML19360, Phone: 973-235-5000
PARIS 75181, France; Recruiting
MULHOUSE 68070, France; Recruiting
NANTES 44035, France; Recruiting
CLERMONT-FERRAND 63003, France; Recruiting
ROUEN 76031, France; Recruiting
MARSEILLE 13305, France; Recruiting
ECHIROLLES 38130, France; Recruiting
BORDEAUX 33076, France; Recruiting
TOULOUSE 31059, France; Recruiting
PARIS 75010, France; Recruiting
PARIS 75674, France; Recruiting
PARIS 75651, France; Recruiting
AMIENS 80054, France; Recruiting
SAINT-ETIENNE 4200, France; Recruiting
ANGERS 49933, France; Recruiting
MONTPELLIER 34295, France; Recruiting
LOMME 59160, France; Recruiting
NICE 06202, France; Recruiting
MARSEILLE 13285, France; Recruiting
LILLE 59037, France; Recruiting
CAEN 14033, France; Recruiting
ORLEANS 45032, France; Recruiting
AIX EN PROVENCE 13616, France; Recruiting
CANNES 06401, France; Recruiting
PARIS 75012, France; Recruiting
RENNES 35056, France; Recruiting
BONNEVILLE 74136, France; Recruiting
Additional Information
Starting date: June 2007
Ending date: December 2008
Last updated: October 15, 2008
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