Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer (InoPro)
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry. |
- 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 ]
- 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 ]
| Enrollment: | 180 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 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 |
Male with Prostate Cancer suffering from Osteoporosis
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 More Information
No publications provided
| Responsible Party: | Trial Transparency Team, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00816452 History of Changes |
| Other Study ID Numbers: | RISED_L_04261 |
| Study First Received: | December 31, 2008 |
| Last Updated: | November 2, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Sanofi:
|
Osteoporosis Prostate Cancer Osteoporosis in male with Prostate Cancer |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis Prostatic Neoplasms Bone Diseases Musculoskeletal Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013