Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment (BONA)

Bayer

Status: Completed

Conditions: Osteolysis; Multiple Myeloma; Prostatic Neoplasms; Breast Neoplasms

Treatments: Drug: Clodronate (Bonefos, BAY94-8393)

Study type: Observational

Funder types: Industry

Identifiers

NCT01198457

14561

BO0910CZ (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

147 participants in 1 patient group

Group 1

Treatment:

Drug: Clodronate (Bonefos, BAY94-8393)