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Completed

NCT Number: NCT00048061

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

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Key information

Conditions

Post Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

2.5mg po daily

Calcium

Dietary Supplement

500 mg/day

Vitamin D

Dietary Supplement

400 IU/day

Primary outcomes

  1. Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density

    Time frame: From Baseline (Month 0) to Month 12

    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.

Secondary outcomes

  1. Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD

    Time frame: From Baseline (Month 0) to Month 24

    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.

  2. Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD

    Time frame: From Baseline (Month 0) to Months 12 and 24

    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.

  3. Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD

    Time frame: From Baseline (Month 0) to Months 12 and 24

    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.

  4. Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.

    Time frame: From Baseline (Month 0) to Months 12 and 24

    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

  5. Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: 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.

  6. Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: Months 12 and 24

    A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.

  7. Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: Months 12 and 24

    A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.

  8. Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: Months 12 and 24

    A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.

  9. Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: 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.

  10. Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: 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.

  11. Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

    Time frame: 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.

  12. Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24

    Time frame: From Baseline (Month 0) to Months 3, 6, 12, 24

    Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).

  13. Absolute Change In Baseline in Serum CTX to Months 12 and 24

    Time frame: From Baseline (Month 0) 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).

  14. Number of Participants With Any Adverse Events and Serious Adverse Event

    Time frame: Up to Month 24

    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.

  15. Number Of Participants With Marked Laboratory Abnormalities

    Time frame: Up to Month 24

    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].

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Oct 25, 2002
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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