A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545207

Purpose

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Post-Menopausal Osteopenia	Drug: ibandronate [Bonviva/Boniva] Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Menopause

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 12 arms ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
Bone density, trabecular BV/TV at distal tibia [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
Serum CTX [ Time Frame: Intervals throughout study ] [ Designated as safety issue: No ]
Lumbar hip and wrist BMD [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	150
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 2 years
Placebo Comparator: 2	Drug: Placebo po monthly for 2 years

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

post-menopausal women, aged 55-75 years;
diagnosed osteopenia.

Exclusion Criteria:

history of osteoporotic vertebral fracture;
contraindication to ibandronate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545207

Locations

France

Lyon, France, 69437

Paris, France, 75475

Saint-priest En Jarez, France, 42277

Toulouse, France, 31059

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545207 History of Changes
Other Study ID Numbers:	ML19357
Study First Received:	October 16, 2007
Last Updated:	January 18, 2011
Health Authority:	France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:

Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid

Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012