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

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: ibandronate [Bonviva/Boniva]; Drug: Placebo

• 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

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-28
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

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