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

Tracking Information

First Received Date ^ICMJE

December 31, 2008

Last Updated Date

September 4, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00816452 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To evaluate incidence of osteopenia/osteoporosis in this study population. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Osteoporosis
Prostate Cancer

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Male

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Public registry GMA

PUBLICREGISTRYGMA@sanofi-aventis.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00816452

Responsible Party

Medical Affairs Study Director, sanofi-aventis administrative office

Study ID Numbers ^ICMJE

RISED_L_04261

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Nurit Tweezer

Sanofi-aventis administrative office Israel

Information Provided By

Sanofi-Aventis

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP