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

NCT01198457 | Completed

• 2 other identifiers: 14561BO0910CZ
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Neoplasms; Prostatic Neoplasms; Multiple Myeloma; Osteolysis

Keywords

Clodronate; Compliance

Outcome Measures

Primary Outcomes (1)

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

  12 months of therapy.

Secondary Outcomes (2)

• 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

Study Arms (1)

Group 1

Drug: Clodronate (Bonefos, BAY94-8393)

Interventions

Clodronate (Bonefos, BAY94-8393) DRUG

Random group of patients in oncology clinic

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Random group of patients in oncology clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Czechia

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Multiple Myeloma; Osteolysis; Patient Compliance

Interventions

Clodronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: September 10, 2010
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

CZ (1)