Trial Information
Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Inclusion Criteria:
- Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline
BMD in between -2 standard deviation (SD) and mean of that among young adults.
Exclusion Criteria:
- Patients with renal or liver problems, on calcium or other bisphosphonate therapy
within six months before enrolling into the study.
Patients who have:
- Serum creatinine levels >212 µmol/L (2.4 mg/dL).
- Creatinine clearance <50 ml/min.
- WBC <4.0x109/L, Hgb <10 g/dL, platelets <140x109/L. Patients with known
hypersensitivity to bisphosphonates. Patients with history of diseases with influence
on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or
osteoporosis.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Bone mineral density of lumber spine
Outcome Time Frame:
12 months after administration of zolderonic acid
Principal Investigator
Chi Fai Ng, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Authority:
Hong Kong: Ethics Committee
Study ID:
CRE-2005.137-T
NCT ID:
NCT00489905
Start Date:
April 2005
Completion Date:
May 2008
Related Keywords:
- Prostatic Neoplasms
- Bone Density
- prostate cancer
- bone mineral density
- Neoplasms
- Prostatic Neoplasms