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

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).

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Key information

Conditions

Breast Neoplasms Behavior Blood Protein Disorders Bone Diseases Bone Resorption Breast Diseases Cardiovascular Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Health Behavior Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Osteolysis Paraproteinemias Patient Acceptance of Health Care Patient Compliance Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clodronate (Bonefos, BAY94-8393)

Drug

Random group of patients in oncology clinic

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

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: BONA

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Sep 10, 2010
Registry last updated: Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed