Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01198457
First received: July 29, 2010
Last updated: September 6, 2012
Last verified: September 2012
  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).


Condition Intervention
Breast Neoplasms
Prostatic Neoplasms
Multiple Myeloma
Osteolysis
Drug: Clodronate (Bonefos, BAY94-8393)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adherence to treatment with oral clodronate (PDC, proportion of days covered). [ Time Frame: 12 months of therapy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy evaluation of the therapy based on incidence of skeletal events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Clodronate (Bonefos, BAY94-8393)
Random group of patients in oncology clinic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Random group of patients in oncology clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198457

Locations
Czech Republic
Many Locations, Czech Republic
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01198457     History of Changes
Other Study ID Numbers: 14561, BO0910CZ
Study First Received: July 29, 2010
Last Updated: September 6, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Bayer:
Clodronate
Compliance

Additional relevant MeSH terms:
Breast Neoplasms
Multiple Myeloma
Neoplasms
Neoplasms, Plasma Cell
Osteolysis
Prostatic Neoplasms
Blood Protein Disorders
Bone Diseases
Bone Resorption
Breast Diseases
Cardiovascular Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Musculoskeletal Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Paraproteinemias
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms
Vascular Diseases
Clodronic Acid
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014