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

Prostate Cancer Clinical Trial

— InoPro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816452
• Other study ID #: RISED_L_04261
• Status: Completed
• Phase: N/A
• First received: December 31, 2008
• Last updated: November 2, 2010
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Israel	Sanofi-aventis administrative office	Natanya

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.		6 months	No
Secondary	To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.		6 months	No
Secondary	To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics		6 months	No
Secondary	To evaluate incidence of osteopenia/osteoporosis in this study population.		6 months	No