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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
BM16549
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Menopausal Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From Baseline (Month 0) to Month 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From Baseline (Month 0) to Month 24
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
From Baseline (Month 0) to Months 12 and 24
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
From Baseline (Month 0) to Months 12 and 24
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
From Baseline (Month 0) to Months 12 and 24
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Months 12 and 24
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Months 12 and 24
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Months 12 and 24
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Months 12 and 24
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Months 12 and 24
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Months 12 and 24
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Months 12 and 24
Secondary outcome [12] 0 0
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).
Timepoint [12] 0 0
From Baseline (Month 0) to Months 3, 6, 12, 24
Secondary outcome [13] 0 0
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).
Timepoint [13] 0 0
From Baseline (Month 0) to Months 12 and 24
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Up to Month 24
Secondary outcome [15] 0 0
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].
Timepoint [15] 0 0
Up to Month 24

Eligibility
Key inclusion criteria
- women 55-80 years of age;

- post-menopausal for >= 5 years;

- ambulatory.
Minimum age
55 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Parkville
Recruitment hospital [3] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5035 - Adelaide
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6979 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Belgium
State/province [16] 0 0
Liege
Country [17] 0 0
Belgium
State/province [17] 0 0
Merksem
Country [18] 0 0
Brazil
State/province [18] 0 0
Campinas
Country [19] 0 0
Brazil
State/province [19] 0 0
Curitiba
Country [20] 0 0
Brazil
State/province [20] 0 0
Porto Alegre
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Czechia
State/province [26] 0 0
Plzen
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha
Country [28] 0 0
Denmark
State/province [28] 0 0
Aalborg
Country [29] 0 0
Denmark
State/province [29] 0 0
Ballerup
Country [30] 0 0
Denmark
State/province [30] 0 0
Vejle
Country [31] 0 0
France
State/province [31] 0 0
Caen
Country [32] 0 0
France
State/province [32] 0 0
Lyon
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Hannover
Country [35] 0 0
Hungary
State/province [35] 0 0
Balatonfuered
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Kiskunhalas
Country [38] 0 0
Hungary
State/province [38] 0 0
Zalaegerszeg
Country [39] 0 0
Italy
State/province [39] 0 0
Siena
Country [40] 0 0
Italy
State/province [40] 0 0
Valeggio Sul Mincio
Country [41] 0 0
Mexico
State/province [41] 0 0
Leon
Country [42] 0 0
Mexico
State/province [42] 0 0
Obregon
Country [43] 0 0
Norway
State/province [43] 0 0
Haugesund
Country [44] 0 0
Norway
State/province [44] 0 0
Oslo
Country [45] 0 0
Norway
State/province [45] 0 0
Stavanger
Country [46] 0 0
Poland
State/province [46] 0 0
Krakow
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Romania
State/province [48] 0 0
Bucharest
Country [49] 0 0
South Africa
State/province [49] 0 0
Cape Town
Country [50] 0 0
South Africa
State/province [50] 0 0
Johannesburg
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Switzerland
State/province [53] 0 0
Zürich
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Cardiff
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Liverpool
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00048061
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications