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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
History of Changes

July 29, 2010
September 6, 2012
January 2009
June 2010   (final data collection date for primary outcome measure)
Adherence to treatment with oral clodronate (PDC, proportion of days covered). [ Time Frame: 12 months of therapy. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01198457 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy of the therapy (skeletal events, pain) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment
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

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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Random group of patients in oncology clinic
  • Breast Neoplasms
  • Prostatic Neoplasms
  • Multiple Myeloma
  • Osteolysis
Drug: Clodronate (Bonefos, BAY94-8393)
Random group of patients in oncology clinic
Group 1
Intervention: Drug: Clodronate (Bonefos, BAY94-8393)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01198457
14561, BO0910CZ
No
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP