Trial information
BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
Status: Completed
Protocol number: ML19360
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
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.
Target sample size is
130
.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Osteoporosis
Intervention type: Drug
Intervention name: ibandronate [Bonviva/Boniva]
Primary outcome: 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
Key secondary outcomes: 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
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.
Gender: Males or Females
Age limits: Min: 30 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 06/27/2007
Date last updated: 11/19/2009
Link to trial result
This trial was conducted at the following locations:
France
- Aix en Provence
- Amiens
- Angers
- Bonneville
- Bordeaux
- Caen
- Cannes
- Clermont-Ferrand
- Echirolles
- Lille
- Lomme
- Marseille
- Montpellier
- Mulhouse
- Nantes
- Nice
- Orleans
- Paris
- Rennes
- Rouen
- Saint-Priest En Jarez
- Toulouse
