Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer

NCT ID: NCT00816452

Last Updated: 2010-11-03

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

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.

Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

Secondary objectives:

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.

Detailed Description

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Conditions

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Osteoporosis Prostate Cancer

Keywords

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Osteoporosis Prostate Cancer Osteoporosis in male with Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Man with Prostate Cancer
* Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
* Osteopenia/osteoporosis proven by bone density test.

Exclusion Criteria

* Creatinine clearance \< 30ml/min
* Hypercalcemia
* Actual treatment by Bisphosphonate or steroids
* Hypersensibility to Bisphosphonate or any contraindication to its use.
* Metastatic prostate Cancer
* Patients not suitable for compliance.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Nurit Tweezer

Role: STUDY_DIRECTOR

Sanofi-aventis administrative office Israel

Locations

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Sanofi-aventis administrative office

Netanya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RISED_L_04261

Identifier Type: -

Identifier Source: org_study_id