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

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.

Study Overview

• Status: Completed
• Conditions: Post Menopausal Osteoporosis
• Intervention / Treatment: Drug: Ibandronate [Bonviva/Boniva]; Drug: Ibandronate [Bonviva/Boniva]; Drug: Ibandronate [Bonviva/Boniva]; Drug: Ibandronate [Bonviva/Boniva]; Dietary supplement: Calcium; Dietary supplement: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 1609
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2N6
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
  • Quebec
    • Quebec City, Quebec, Canada, G1V 3M7
• Czechia
  • Plzen, Czechia, 305 99
  • Praha, Czechia, 128 00
  • Praha, Czechia, 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, 1083
  • Budapest, Hungary, 1036
  • 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
• 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
  • Colorado
    • Lakewood, Colorado, United States, 80227
  • Florida
    • Gainesville, Florida, United States, 32607
  • Maryland
    • Bethesda, Maryland, United States, 20817
    • Wheaton, Maryland, United States, 20902
  • Missouri
    • Saint Louis, Missouri, United States, 63110
  • Montana
    • Billings, Montana, United States, 59120
  • Nebraska
    • Omaha, Nebraska, United States, 68131
  • New Jersey
    • Livingston, New Jersey, United States, 07039
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • Oregon
    • Portland, Oregon, United States, 97213
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
  • Texas
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Richmond, Virginia, United States, 23294
  • Washington
    • Seattle, Washington, United States, 98144
  • Wisconsin
    • Madison, Wisconsin, United States, 53792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly on a single day; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly over 2 consecutive days; Drug: Ibandronate [Bonviva/Boniva]; 150mg po monthly; 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]; 2.5mg po daily; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly on a single day; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly over 2 consecutive days; Drug: Ibandronate [Bonviva/Boniva]; 150mg po monthly; 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]; 2.5mg po daily; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly on a single day; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly over 2 consecutive days; Drug: Ibandronate [Bonviva/Boniva]; 150mg po monthly; 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]; 2.5mg po daily; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly on a single day; Drug: Ibandronate [Bonviva/Boniva]; 100mg po monthly over 2 consecutive days; Drug: Ibandronate [Bonviva/Boniva]; 150mg po monthly; Dietary supplement: Calcium; 500 mg/day; Dietary supplement: Vitamin D; 400 IU/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD	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.	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	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.	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	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.	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.	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	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	A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.	Months 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24	A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.	Months 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24	A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.	Months 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24	A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.	Months 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24	A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.	Months 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24	A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.	Months 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24	A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.	Months 12 and 24
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24	Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).	From Baseline (Month 0) to Months 3, 6, 12, 24
Absolute Change In Baseline in Serum CTX to Months 12 and 24	Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).	From Baseline (Month 0) to Months 12 and 24
Number of Participants With Any Adverse Events and Serious Adverse Event	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.	Up to Month 24
Number Of Participants With Marked Laboratory Abnormalities	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].	Up to Month 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: October 24, 2002
• First Submitted That Met QC Criteria: October 24, 2002
• First Posted (Estimate): October 25, 2002

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Ibandronic Acid
• Other Study ID Numbers: BM16549