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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