DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Placebo (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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.

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

Primary outcome: 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).

Secondary outcome:

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

Pain control

Analgesic medication

Hospitalization

AEs and laboratory parameters

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Aix En Provence 13616, France

Amiens 80054, France

Angers 49033, France

Bonneville 74136, France

Bordeaux 33076, France

Caen 14033, France

Cannes 06401, France

Clermont-ferrand 63003, France

Echirolles 38434, France

Lille 59037, France

Lomme 59462, France

Marseille 13285, France

Marseille 13385, France

Montpellier 34295, France

Mulhouse 68070, France

Nantes 44035, France

Nice 06202, France

Orleans 45000, France

Paris 75674, France

Paris 75181, France

Paris 75475, France

Paris 75651, France

Paris 75571, France

Rennes 35203, France

Rouen 76031, France

Saint-priest En Jarez 42277, France

Toulouse 31059, France

Additional Information

Starting date: June 2007
Last updated: August 17, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017