MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
1 other identifier
interventional
1,609
19 countries
68
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2002
Typical duration for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 24, 2002
CompletedFirst Posted
Study publicly available on registry
October 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedResults Posted
Study results publicly available
May 30, 2016
CompletedMarch 29, 2018
February 1, 2018
2.7 years
October 24, 2002
February 5, 2016
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
From Baseline (Month 0) to Month 12
Secondary Outcomes (15)
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
From Baseline (Month 0) to Month 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
From Baseline (Month 0) to Months 12 and 24
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
From Baseline (Month 0) to Months 12 and 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
From Baseline (Month 0) to Months 12 and 24
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
Months 12 and 24
- +10 more secondary outcomes
Study Arms (4)
Ibandronate 2.5 mg
ACTIVE COMPARATORParticipants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .
Ibandronate 50/50 mg
EXPERIMENTALParticipants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate 100 mg
EXPERIMENTALParticipants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Ibandronate 150 mg
EXPERIMENTALParticipants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Interventions
Eligibility Criteria
You may qualify if:
- women 55-80 years of age;
- post-menopausal for \>= 5 years;
- ambulatory.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Unknown Facility
Irvine, California, 92618, United States
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Loma Linda, California, 92357, United States
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Los Angeles, California, 90211, United States
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Oakland, California, 94612, United States
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Rancho Mirage, California, 92270, United States
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Lakewood, Colorado, 80227, United States
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Gainesville, Florida, 32607, United States
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Bethesda, Maryland, 20817, United States
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Wheaton, Maryland, 20902, United States
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St Louis, Missouri, 63110, United States
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Billings, Montana, 59120, United States
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Omaha, Nebraska, 68131, United States
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Livingston, New Jersey, 07039, United States
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Albuquerque, New Mexico, 87106, United States
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Portland, Oregon, 97213, United States
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Wyomissing, Pennsylvania, 19610, United States
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San Antonio, Texas, 78229, United States
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Richmond, Virginia, 23294, United States
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Seattle, Washington, 98144, United States
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Madison, Wisconsin, 53792, United States
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Adelaide, 5000, Australia
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Adelaide, 5035, Australia
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Parkville, 3052, Australia
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Perth, 6979, Australia
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Liège, 4020, Belgium
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Merksem, 2170, Belgium
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Campinas, 13077-005, Brazil
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Curitiba, 80060-240, Brazil
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Porto Alegre, 90035-003, Brazil
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São Paulo, 04026-000, Brazil
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Calgary, Alberta, T2N 4N1, Canada
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Vancouver, British Columbia, V5Z 2N6, Canada
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Toronto, Ontario, M5S 1B2, Canada
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Québec, Quebec, G1V 3M7, Canada
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Pilsen, 305 99, Czechia
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Prague, 128 00, Czechia
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Prague, 169 02, Czechia
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Aalborg, 9000, Denmark
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Ballerup Municipality, 2750, Denmark
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Vejle, 7100, Denmark
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Caen, 14033, France
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Lyon, 69437, France
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Berlin, 12200, Germany
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Hanover, 30167, Germany
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Balatonfüred, 8230, Hungary
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Budapest, 1036, Hungary
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Budapest, 1083, Hungary
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Kiskunhalas, 6400, Hungary
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Zalaegerszeg, 8900, Hungary
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Siena, 53100, Italy
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Valeggio sul Mincio, 37067, Italy
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León, 37000, Mexico
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Obregón, 85100, Mexico
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Haugesund, 5507, Norway
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Oslo, 0176, Norway
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Stavanger, 4010, Norway
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Krakow, 31-501, Poland
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Warsaw, 04-730, Poland
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Bucharest, 011025, Romania
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Cape Town, 7500, South Africa
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Johannesburg, 2196, South Africa
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Barcelona, 08907, Spain
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Madrid, 28041, Spain
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Zurich, 8091, Switzerland
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Cardiff, CF64 2XX, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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London, E11 1NR, United Kingdom
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Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2002
First Posted
October 25, 2002
Study Start
April 1, 2002
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
March 29, 2018
Results First Posted
May 30, 2016
Record last verified: 2018-02