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

Hoffmann-La Roche68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoporosis

Interventions

PlaceboDRUG

Placebo i.v. single dose

ibandronate [Bonviva/Boniva]DRUG

3mg i.v. single dose

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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 (27)

Unnamed facility

Aix-en-Provence, France

Unnamed facility

Amiens, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

Percentage of patients with >=50% diminution of pain between day 0 and 7

Time frame: Day 7

Pain control

Time frame: Day 7 and 1 month

Analgesic medication

Time frame: 1 month

Hospitalization

Time frame: 1 month

AEs and laboratory parameters

Time frame: Throughout study

Data from ClinicalTrials.gov

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