Trial Condition(s):
Breast Neoplasms, Prostatic Neoplasms, Multiple myeloma, Osteolysis
Study to investigate adherence of patients to clodronate (Bonefos) treatment (BONA)
Bayer Identifier:
14561
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
Inclusion Criteria
- Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors - Bone metastases - Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos. - By agreeing to usage of patients diaries and goodwill with accounting of tablets
Exclusion Criteria
- According to SmPC (Summary of Product Characteristics) Bonefos.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Czech Republic | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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 skeletal events
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Adherence to treatment with oral clodronate (PDC, proportion of days covered).Timeframe: 12 months of therapy.
Secondary Outcome
- Efficacy evaluation of the therapy based on incidence of skeletal eventsTimeframe: 12 months
- Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaireTimeframe: 12 months
Additional Information
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