Official Title: “A Randomized, Double-Blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis”

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration.

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: ibandronate [Bonviva/Boniva]
  • 2mg iv every 2 months
• Drug: ibandronate [Bonviva/Boniva]
  • 2.5mg po daily
• Drug: ibandronate [Bonviva/Boniva]
  • 3mg iv every 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Active Comparator: 4

Primary Measures

• Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD)
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Relative change in mean lumbar spine BMD
  • Time Frame: 24 months
    Safety Issue?: No
• Relative and absolute change in total hip, trochanter, femoral neck BMD
  • Time Frame: 12 and 24 months
    Safety Issue?: No
• Percentage of responders
  • Time Frame: 12 and 24 months
    Safety Issue?: No
• Change from baseline in fastin serum CTX
  • Time Frame: 3, 6, 12 and 24 months
    Safety Issue?: No
• AEs, laboratory parameters
  • Time Frame: Throughout study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00048074

Study ID Number: BM16550

ClinicalTrials.gov Identifier: NCT00048074

Health Authority: United States: Food and Drug Administration