BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
- Registration Number
- NCT00493623
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ibandronate [Bonviva/Boniva] - 2 Placebo -
- Primary Outcome Measures
Name Time Method 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). Day 7
- Secondary Outcome Measures
Name Time Method Analgesic medication 1 month Hospitalization 1 month Percentage of patients with >=50% diminution of pain between day 0 and 7 Day 7 Pain control Day 7 and 1 month AEs and laboratory parameters Throughout study