- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00816452
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.
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Natanya, Israel
- Sanofi-Aventis Administrative Office
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
Tidsram: 6 months
|
6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
Tidsram: 6 months
|
6 months
|
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics
Tidsram: 6 months
|
6 months
|
To evaluate incidence of osteopenia/osteoporosis in this study population.
Tidsram: 6 months
|
6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Nurit Tweezer, Sanofi-aventis administrative office Israel
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RISED_L_04261
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