Trial Condition(s):

Breast Neoplasms, Prostatic Neoplasms, Multiple myeloma, Osteolysis

Study to investigate adherence of patients to clodronate (Bonefos) treatment (BONA)

Bayer Identifier:

14561

ClinicalTrials.gov Identifier:

NCT01198457

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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 Summary

Enrollment Goal
147
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Bonefos (Clodronate, BAY94-8393)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Czech Republic

Status
Completed
 

Trial Design