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

Multiple Myeloma Clinical Trial

— BONA  

Official title:

BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skeletal Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198457
• Other study ID #: 14561
• Secondary ID: BO0910CZ
• Status: Completed
• Phase: N/A
• First received: July 29, 2010
• Last updated: September 6, 2012
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Multiple Myeloma
• Neoplasms
• Osteolysis
• Prostatic Neoplasms

Intervention

Drug:
• Clodronate (Bonefos, BAY94-8393)
Random group of patients in oncology clinic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to treatment with oral clodronate (PDC, proportion of days covered).		12 months of therapy.	No
Secondary	Efficacy evaluation of the therapy based on incidence of skeletal events		12 months	No
Secondary	Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire		12 months	No

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