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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00816452

Purpose

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.

Condition
Osteoporosis Prostate Cancer

MedlinePlus related topics: Cancer Osteoporosis Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	600
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Male with Prostate Cancer suffering from Osteoporosis

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816452

Contacts

Contact: Public registry GMA

PUBLICREGISTRYGMA@sanofi-aventis.com

Locations

Israel
Sanofi-aventis administrative office
Natanya, Israel

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Nurit Tweezer

Sanofi-aventis administrative office Israel

More Information

Responsible Party:	sanofi-aventis administrative office ( Medical Affairs Study Director )
Study ID Numbers:	RISED_L_04261
Study First Received:	December 31, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00816452
Health Authority:	Israel: Ministry of Health

Keywords provided by Sanofi-Aventis:

Osteoporosis
Prostate Cancer
Osteoporosis in male with Prostate Cancer

Study placed in the following topic categories:

Diphosphonates
Prostatic Diseases
Genital Neoplasms, Male
Musculoskeletal Diseases
Osteoporosis

Urogenital Neoplasms
Bone Diseases, Metabolic
Genital Diseases, Male
Bone Diseases
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009