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

Osteoporosis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493623
• Other study ID #: ML19360
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2007
• Last updated: March 1, 2016
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporotic Fractures

Intervention

Drug:
• Placebo
Placebo i.v. single dose
• ibandronate [Bonviva/Boniva]
3mg i.v. single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of patients with >=50% diminution of pain between day 0 and 7		Day 7	No
Secondary	Pain control		Day 7 and 1 month	No
Secondary	Analgesic medication		1 month	No
Secondary	Hospitalization		1 month	No
Secondary	AEs and laboratory parameters		Throughout study	Yes