BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Overview

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Full Title of Study: “A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

Interventions

  • Drug: ibandronate [Bonviva/Boniva]
    • 150mg po monthly for 6 months (+ feedback)
  • Drug: ibandronate [Bonviva/Boniva]
    • 150mg po monthly for 6 months (- feedback)

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
    • Time Frame: 6 months

Secondary Measures

  • Patient satisfaction by OPSAT-Q and OPPS.
    • Time Frame: 6 months
  • Tolerability; SAEs.
    • Time Frame: Throughout study

Participating in This Clinical Trial

Inclusion Criteria

  • ambulatory post-menopausal women with osteoporosis; – 55-85 years of age; – eligible for bisphosphonate treatment; – naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago). Exclusion Criteria:

  • inability to stand or sit in an upright position for at least 60 minutes; – inability to swallow a tablet whole; – hypersensitivity to bisphosphonates; – administration of any drug, or presence of active disease, known to influence bone metabolism; – uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism; – history of major upper gastrointestinal disease.

Gender Eligibility: Female

Minimum Age: 55 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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