Trial Information
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
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Adherence to treatment with oral clodronate (PDC, proportion of days covered).
Outcome Time Frame:
12 months of therapy.
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Czech Republic: State Institute for Drug Control
Study ID:
14561
NCT ID:
NCT01198457
Start Date:
January 2009
Completion Date:
June 2010
Related Keywords:
- Breast Neoplasms
- Prostatic Neoplasms
- Multiple Myeloma
- Osteolysis
- Clodronate
- Compliance
- Breast Neoplasms
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Osteolysis
- Prostatic Neoplasms