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

Roche

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493623

ML19360

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

2

Placebo Comparator group

Treatment:

Drug: Placebo