Breast Neoplasms, Multiple Myeloma, Osteolysis, Prostatic Neoplasms
Conditions
Keywords
Clodronate, Compliance
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).
Interventions
DRUGClodronate (Bonefos, BAY94-8393)
Random group of patients in oncology clinic
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to treatment with oral clodronate (PDC, proportion of days covered). | 12 months of therapy. |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation of the therapy based on incidence of skeletal events | 12 months |
| Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire | 12 months |
Countries
Czechia
Outcome results
None listed