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: April 22, 2016
Last verified: April 2016
  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]
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density [ Time Frame: From Baseline (Month 0) to Month 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD [ Time Frame: From Baseline (Month 0) to Month 24 ] [ Designated as safety issue: No ]
    Relative change in 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 24 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 24.

  • Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ] [ Designated as safety issue: No ]
    The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.

  • Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ] [ Designated as safety issue: No ]
    Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.

  • Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ] [ Designated as safety issue: No ]
    Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center

  • Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.

  • Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.

  • Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.

  • Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.

  • Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.

  • Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.

  • Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
    A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.

  • Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 [ Time Frame: From Baseline (Month 0) to Months 3, 6, 12, 24 ] [ Designated as safety issue: No ]
    Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).

  • Absolute Change In Baseline in Serum CTX to Months 12 and 24 [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ] [ Designated as safety issue: No ]
    Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).

  • Number of Participants With Any Adverse Events and Serious Adverse Event [ Time Frame: Up to Month 24 ] [ Designated as safety issue: No ]
    An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

  • Number Of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Month 24 ] [ Designated as safety issue: No ]
    Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].


Enrollment: 1609
Study Start Date: April 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibandronate 2.5 mg
Participants 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 .
Drug: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
Experimental: Ibandronate 50/50 mg
Participants 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.
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
Experimental: Ibandronate 100 mg
Participants 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
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day
Experimental: Ibandronate 150 mg
Participants 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
Drug: Ibandronate [Bonviva/Boniva]
150mg po monthly
Dietary Supplement: Calcium
500 mg/day
Dietary Supplement: Vitamin D
400 IU/day

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
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, 128 00
Praha, Czech Republic, 169 02
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048061     History of Changes
Other Study ID Numbers: BM16549 
Study First Received: October 24, 2002
Results First Received: February 5, 2016
Last Updated: April 22, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Ibandronic acid
Calcium, Dietary
Diphosphonates
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2016