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

N/ACompletedNCT01198457

Bayer147 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

147

Conditions

Breast Neoplasms Prostatic Neoplasms Multiple Myeloma Osteolysis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Adherence to treatment with oral clodronate (PDC, proportion of days covered).

Time frame: 12 months of therapy.

Secondary Outcomes

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