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

NCT ID: NCT01198457

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Neoplasms Prostatic Neoplasms Multiple Myeloma Osteolysis

Keywords

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Clodronate Compliance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Clodronate (Bonefos, BAY94-8393)

Intervention Type DRUG

Random group of patients in oncology clinic

Interventions

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Clodronate (Bonefos, BAY94-8393)

Random group of patients in oncology clinic

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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BO0910CZ

Identifier Type: OTHER

Identifier Source: secondary_id

14561

Identifier Type: -

Identifier Source: org_study_id