Clinical Trial: Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skel
Brief Summary: Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Adherence to treatment with oral clodronate (PDC, proportion of days covered). [ Time Frame: 12 months of therapy. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Efficacy evaluation of the therapy based on incidence of skeletal events [ Time Frame: 12 months ]
- Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire [ Time Frame: 12 months ]
Original Secondary Outcome: Efficacy of the therapy (skeletal events, pain) [ Time Frame: 12 months ]
Information By: Bayer
Dates:
Date Received: July 29, 2010
Date Started: January 2009
Date Completion:
Last Updated: September 6, 2012
Last Verified: September 2012
