Trial Information

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

Status: Recruiting

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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 30 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2007

Trial Registration Date: 06/27/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: September 22, 2008 at 2:53:47 PM