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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048061
First received: October 24, 2002
Last updated: May 13, 2009
Last verified: May 2009
History of Changes

October 24, 2002
May 13, 2009
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Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00048061 on ClinicalTrials.gov Archive Site
  • Relative change in mean lumbar spine BMD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Relative and absolute change in total hip, trochanter, femoral neck BMD [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in fasting serum CTX [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
A Randomized, Double-Blind Study Comparing the Effect of Monthly Versus Daily Treatment With Oral Bonviva on Lumbar Bone Mineral Density in Women With 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post-Menopausal Osteoporosis
  • Drug: ibandronate [Bonviva/Boniva]
    2.5mg po daily
  • Drug: ibandronate [Bonviva/Boniva]
    100mg po monthly on a single day
  • Drug: ibandronate [Bonviva/Boniva]
    100mg po monthly over 2 consecutive days
  • Drug: ibandronate [Bonviva/Boniva]
    150mg po monthly
  • Active Comparator: 1
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Experimental: 2
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Experimental: 3
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Experimental: 4
    Intervention: Drug: ibandronate [Bonviva/Boniva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1609
April 2005
Not Provided

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.
Female
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Italy,   Mexico,   Norway,   Poland,   Romania,   South Africa,   Spain,   Switzerland,   United Kingdom
 
NCT00048061
BM16549
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP