Awareness to Osteopenia’s Treatment by Bisphosphonate in Male Suffering From Prostate Cancer
Overview
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.
Full Title of Study: “Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy – Registry.”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: July 2010
Clinical Trial Outcome Measures
Primary Measures
- To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
- Time Frame: 6 months
Secondary Measures
- To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
- Time Frame: 6 months
- To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics
- Time Frame: 6 months
- To evaluate incidence of osteopenia/osteoporosis in this study population.
- Time Frame: 6 months
Participating in This Clinical Trial
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.
Gender Eligibility: Male
Minimum Age: 60 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Sanofi
- Provider of Information About this Clinical Study
- Trial Transparency Team, sanofi-aventis
- Overall Official(s)
- Nurit Tweezer, Study Director, Sanofi-aventis administrative office Israel
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