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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01198457
First Posted: September 10, 2010
Last Update Posted: September 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
July 29, 2010
September 10, 2010
September 7, 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. ]
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 ]
  • Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire [ Time Frame: 12 months ]
Efficacy of the therapy (skeletal events, pain) [ Time Frame: 12 months ]
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
 
NCT01198457
14561
BO0910CZ ( Other Identifier: Company Internal )
No
Not Provided
Not Provided
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2012