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

Completed

• Conditions: Breast Neoplasms; Prostatic Neoplasms; Multiple Myeloma; Osteolysis
• Interventions: Drug: Clodronate (Bonefos, BAY94-8393)

• Registration Number: NCT01198457
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

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Exclusion Criteria

• According to SmPC (Summary of Product Characteristics) Bonefos.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Clodronate (Bonefos, BAY94-8393)	-

Primary Outcome Measures

Name	Time	Method
Adherence to treatment with oral clodronate (PDC, proportion of days covered).	12 months of therapy.

Secondary Outcome Measures

Name	Time	Method
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