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Completed

NCT Number: NCT00493623

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo i.v. single dose

ibandronate [Bonviva/Boniva]

Drug

3mg i.v. single dose

Primary outcomes

  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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 28, 2007
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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