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

Post Menopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048061
• Other study ID #: BM16549
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2002
• Last updated: February 28, 2018
• Start date: April 2002
• Est. completion date: December 2004

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1609
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Drug:
• Ibandronate [Bonviva/Boniva]
2.5mg po daily
• Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
• Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
• Ibandronate [Bonviva/Boniva]
150mg po monthly

Dietary Supplement:
• Calcium
500 mg/day
• Vitamin D
400 IU/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Mexico,  Norway,  Poland,  Romania,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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