Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer
InoPro
Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.
1 other identifier
observational
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2008
CompletedFirst Posted
Study publicly available on registry
January 1, 2009
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 3, 2010
November 1, 2010
1.5 years
December 31, 2008
November 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
6 months
Secondary Outcomes (3)
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
6 months
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics
6 months
To evaluate incidence of osteopenia/osteoporosis in this study population.
6 months
Eligibility Criteria
Male with Prostate Cancer suffering from Osteoporosis
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-aventis administrative office
Netanya, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nurit Tweezer
Sanofi-aventis administrative office Israel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 31, 2008
First Posted
January 1, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 3, 2010
Record last verified: 2010-11