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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048061
First received: October 24, 2002
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients wil l 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+ individ uals.


Condition Intervention Phase
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Phase 3

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:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 Start Date: April 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Irvine, California, United States, 92618
Loma Linda, California, United States, 92357
Los Angeles, California, United States, 90211
Oakland, California, United States, 94612
Rancho Mirage, California, United States, 92270
United States, Colorado
Lakewood, Colorado, United States, 80227
United States, Florida
Gainesville, Florida, United States, 32607
United States, Maryland
Bethesda, Maryland, United States, 20817
Wheaton, Maryland, United States, 20902
United States, Missouri
St Louis, Missouri, United States, 63110
United States, Montana
Billings, Montana, United States, 59120
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, Oregon
Portland, Oregon, United States, 97213
United States, Pennsylvania
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Richmond, Virginia, United States, 23294
United States, Washington
Seattle, Washington, United States, 98144
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Australia
Adelaide, Australia, 5000
Adelaide, Australia, 5035
Parkville, Australia, 3052
Perth, Australia, 6979
Belgium
Liege, Belgium, 4020
Merksem, Belgium, 2170
Brazil
Campinas, Brazil, 13077-005
Curitiba, Brazil, 80060-240
Porto Alegre, Brazil, 90035-003
Sao Paulo, Brazil, 04026-000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 2N6
Canada, Ontario
Toronto, Ontario, Canada, M5S 1B2
Canada, Quebec
Quebec City, Quebec, Canada, G1V 3M7
Czech Republic
Plzen, Czech Republic, 305 99
Praha, Czech Republic, 169 02
Praha, Czech Republic, 128 00
Denmark
Aalborg, Denmark, 9000
Ballerup, Denmark, 2750
Vejle, Denmark, 7100
France
Caen, France, 14033
Lyon, France, 69437
Germany
Berlin, Germany, 12200
Hannover, Germany, 30167
Hungary
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1036
Budapest, Hungary, 1083
Kiskunhalas, Hungary, 6400
Zalaegerszeg, Hungary, 8900
Italy
Siena, Italy, 53100
Valeggio Sul Mincio, Italy, 37067
Mexico
Leon, Mexico, 37000
Obregon, Mexico, 85100
Norway
Haugesund, Norway, 5507
Oslo, Norway, 0176
Stavanger, Norway, 4010
Poland
Krakow, Poland, 31-501
Warszawa, Poland, 04-730
Romania
Bucharest, Romania, 011025
South Africa
Cape Town, South Africa, 7500
Johannesburg, South Africa, 2196
Spain
Barcelona, Spain, 08907
Madrid, Spain, 28041
Switzerland
Zürich, Switzerland, 8091
United Kingdom
Cardiff, United Kingdom, CF64 2XX
Liverpool, United Kingdom, L22 0LG
London, United Kingdom, E11 1NR
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048061     History of Changes
Other Study ID Numbers: BM16549
Study First Received: October 24, 2002
Last Updated: August 26, 2014
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 August 28, 2014