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

November 2, 2010 updated by: Sanofi

Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Natanya, Israel
    - Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male with Prostate Cancer suffering from Osteoporosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis. Time Frame: 6 months	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

Study Director: Nurit Tweezer, Sanofi-aventis administrative office Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)