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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post Menopausal Osteoporosis

Intervention / Treatment
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* Drug: Ibandronate [Bonviva/Boniva]
* Drug: Ibandronate [Bonviva/Boniva]
* Drug: Ibandronate [Bonviva/Boniva]
* Drug: Ibandronate [Bonviva/Boniva]
* Dietary Supplement: Calcium
* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibandronate 2.5 mg<br>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]<br>* 2.5mg po daily<br>Dietary Supplement: Calcium<br>* 500 mg/day<br>Dietary Supplement: Vitamin D<br>* 400 IU/day<br>|
| Experimental: Ibandronate 50/50 mg<br>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]<br>* 100mg po monthly on a single day<br>Dietary Supplement: Calcium<br>* 500 mg/day<br>Dietary Supplement: Vitamin D<br>* 400 IU/day<br>|
| Experimental: Ibandronate 100 mg<br>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]<br>* 100mg po monthly over 2 consecutive days<br>Dietary Supplement: Calcium<br>* 500 mg/day<br>Dietary Supplement: Vitamin D<br>* 400 IU/day<br>|
| Experimental: Ibandronate 150 mg<br>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]<br>* 150mg po monthly<br>Dietary Supplement: Calcium<br>* 500 mg/day<br>Dietary Supplement: Vitamin D<br>* 400 IU/day<br>|

What is the study measuring?
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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 |