check_circleStudy Completed

Breast Neoplasms, Prostatic Neoplasms, Multiple myeloma, Osteolysis

Bayer Identifier:

14561

ClinicalTrials.gov Identifier:

NCT01198457

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to investigate adherence of patients to clodronate (Bonefos) treatment

Trial 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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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



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

Trial summary

Enrollment Goal
147
Trial Dates
January 2009 - June 2010
Phase
N/A
Could I Receive a placebo
No
Products
Bonefos (Clodronate, BAY94-8393)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Czech Republic

Primary Outcome

  • Adherence to treatment with oral clodronate (PDC, proportion of days covered).
    date_rangeTime Frame:
    12 months of therapy.
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    Safety Issue:
    No

Secondary Outcome

  • Efficacy evaluation of the therapy based on incidence of skeletal events
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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