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

Completed

• Conditions: Osteoporosis; Prostate Cancer

• Registration Number: NCT00816452
• Lead Sponsor: Sanofi

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Study Start: 2009-01
• Study First Posted: 2009-01-01
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-02
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.	6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.	6 months
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics	6 months
To evaluate incidence of osteopenia/osteoporosis in this study population.	6 months

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇮🇱 Natanya, Israel