A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva - Full Text View

Purpose

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase IV

MedlinePlus related topics:

Menopause Osteoporosis

ChemIDplus related topics:

Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Double-Blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in mean total hip BMD [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative change in serum CTX [ Time Frame: Trough and peak suppression ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	719
Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 3 years
2: Active Comparator	Drug: ibandronate [Bonviva/Boniva] 100mg po monthly for 3 years

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

successful completion of Bonviva study BM16549, with at least 75% compliance;
ambulatory.

Exclusion Criteria:

malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
breast cancer diagnosed within the previous 22 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081653

Show 31 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MA17903
First Received:	April 19, 2004
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00081653
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ibandronic acid

Musculoskeletal Diseases

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00081653