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Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer


N/A
50 Years
80 Years
Open (Enrolling)
Male
Prostatic Neoplasms, Bone Density

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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 ┬Ámol/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

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