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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048061

Purpose

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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 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 Comparing the Effect of Monthly Versus Daily Treatment With Oral Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Menopause Minerals Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in mean lumbar spine BMD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Relative and absolute change in total hip, trochanter, femoral neck BMD [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change from baseline in fasting serum CTX [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	1609
Study Completion Date:	April 2005

Arms	Assigned Interventions
Active Comparator: 1	Drug: ibandronate [Bonviva/Boniva] 2.5mg po daily
Experimental: 2	Drug: ibandronate [Bonviva/Boniva] 100mg po monthly on a single day
Experimental: 3	Drug: ibandronate [Bonviva/Boniva] 100mg po monthly over 2 consecutive days
Experimental: 4	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women 55-80 years of age;
post-menopausal for >= 5 years;
ambulatory.

Exclusion Criteria:

malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
breast cancer within the previous 20 years;
allergy to bisphosphonates;
previous treatment with an intravenous bisphosphonate at any time;
previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048061

Show 68 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048061 History of Changes
Other Study ID Numbers:	BM16549
Study First Received:	October 24, 2002
Last Updated:	May 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012