Clinical Trial: A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis

Brief Summary: This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of Participants With Adherence to Treatment [ Time Frame: Up to 6 months ]

Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.


Original Primary Outcome: Comparison of the proportion of patients with >=83% adherence at 6 months (ie 5 of 6 possible administrations)to Bonviva in the feedback vs no feedback group.

Current Secondary Outcome:

  • Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores [ Time Frame: At Month 6 ]
    The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.
  • Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score [ Time Frame: At Month 6 ]
    OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.
  • Percent Change From Baseline in CTX Based on Adherence to Ibandronate [ Time Frame: Baseline, Month 6 ]
    Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.


Original Secondary Outcome: Patient satisfaction at 6 months, by OPSAT-Q; serum CTX levels; AEs and labs

Information By: Hoffmann-La Roche

Dates:
Date Received: October 16, 2007
Date Started: April 2006
Date Completion:
Last Updated: August 31, 2016
Last Verified: August 2016