Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy
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An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.
Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
histologically confirmed adenocarcinoma of the prostate.
Orchidectomy within the four previous weeks to enter the study.
bone metastasis evidenced by bone scan.
A hip DEXA study with a DS < 3.
No hormonal therapy previous to enter the study.
ECOG performance score of 0-2.
Signed written informed consent.
Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
Any kind of hormonal therapy for prostate cancer previous to enter the study.
Serum calcium corrected for albumin level < 8.0 mg/dl.