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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00048061
Registration number
NCT00048061
Ethics application status
Date submitted
24/10/2002
Date registered
25/10/2002
Date last updated
29/03/2018
Titles & IDs
Public title
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
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Scientific 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
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Secondary ID [1]
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BM16549
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post Menopausal Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Reproductive Health and Childbirth
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ibandronate [Bonviva/Boniva]
Treatment: Drugs - Ibandronate [Bonviva/Boniva]
Treatment: Drugs - Ibandronate [Bonviva/Boniva]
Treatment: Drugs - Ibandronate [Bonviva/Boniva]
Other interventions - Calcium
Other interventions - Vitamin D
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 .
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.
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
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
Treatment: Drugs: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Treatment: Drugs: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Treatment: Drugs: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Treatment: Drugs: Ibandronate [Bonviva/Boniva]
150mg po monthly
Other interventions: Calcium
500 mg/day
Other interventions: Vitamin D
400 IU/day
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline (Month 0) to Month 12
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Secondary outcome [1]
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Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline (Month 0) to Month 24
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Secondary outcome [2]
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Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
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Assessment method [2]
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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.
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Timepoint [2]
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From Baseline (Month 0) to Months 12 and 24
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Secondary outcome [3]
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Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
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Assessment method [3]
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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.
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Timepoint [3]
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From Baseline (Month 0) to Months 12 and 24
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Secondary outcome [4]
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Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
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Assessment method [4]
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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
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Timepoint [4]
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From Baseline (Month 0) to Months 12 and 24
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Secondary outcome [5]
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Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [5]
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A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
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Timepoint [5]
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Months 12 and 24
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Secondary outcome [6]
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Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [6]
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A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
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Timepoint [6]
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Months 12 and 24
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Secondary outcome [7]
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Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [7]
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A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
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Timepoint [7]
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Months 12 and 24
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Secondary outcome [8]
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Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [8]
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A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
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Timepoint [8]
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Months 12 and 24
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Secondary outcome [9]
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Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [9]
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A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
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Timepoint [9]
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Months 12 and 24
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Secondary outcome [10]
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Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [10]
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A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
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Timepoint [10]
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Months 12 and 24
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Secondary outcome [11]
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Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
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Assessment method [11]
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A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
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Timepoint [11]
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Months 12 and 24
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Secondary outcome [12]
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Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
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Assessment method [12]
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Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
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Timepoint [12]
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From Baseline (Month 0) to Months 3, 6, 12, 24
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Secondary outcome [13]
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Absolute Change In Baseline in Serum CTX to Months 12 and 24
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Assessment method [13]
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Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
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Timepoint [13]
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From Baseline (Month 0) to Months 12 and 24
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Secondary outcome [14]
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Number of Participants With Any Adverse Events and Serious Adverse Event
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Assessment method [14]
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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.
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Timepoint [14]
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Up to Month 24
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Secondary outcome [15]
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Number Of Participants With Marked Laboratory Abnormalities
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Assessment method [15]
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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].
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Timepoint [15]
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Up to Month 24
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Eligibility
Key inclusion criteria
- women 55-80 years of age;
- post-menopausal for >= 5 years;
- ambulatory.
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Minimum age
55
Years
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Maximum age
80
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2004
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Sample size
Target
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Accrual to date
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Final
1609
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Parkville
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Recruitment hospital [3]
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- Perth
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5035 - Adelaide
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment postcode(s) [4]
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6979 - Perth
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Missouri
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Montana
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Nebraska
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Liege
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Campinas
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Curitiba
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Porto Alegre
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Ontario
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Plzen
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Praha
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Aalborg
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Caen
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France
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Lyon
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Berlin
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Germany
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Hannover
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Budapest
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Kiskunhalas
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Siena
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Leon
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Haugesund
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Oslo
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Stavanger
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Krakow
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Warszawa
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Romania
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Bucharest
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Johannesburg
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Madrid
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Zürich
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Liverpool
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London
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00048061
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00048061
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