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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00489905
First received: June 20, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes

June 20, 2007
July 6, 2010
April 2005
Not Provided
  • Bone mineral density of lumber spine [ Time Frame: 12 months after administration of zolderonic acid ]
  • Bone mineral density of femoral neck [ Time Frame: 12 months after administration of zolderonic acid ]
Same as current
Complete list of historical versions of study NCT00489905 on ClinicalTrials.gov Archive Site
  • Change in serum creatinine, calcium, phosphate and alkaline phosphatase [ Time Frame: From time of enrollment to 3 months after the last intervention ]
  • Change in creatinine clearance [ Time Frame: From time of enrollment to 3 months after the last intervention ]
Same as current
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Not Provided
 
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostatic Neoplasms
  • Bone Density
Drug: Zolderonic acid (Zometa)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
May 2008
Not Provided

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.
Male
50 Years to 80 Years
Not Provided
Contact: Annie YF Wong (852) 2632 2501 anniewong@surgery.cuhk.edu.hk
China
 
NCT00489905
CRE-2005.137-T, HARECCTR0500010
Not Provided
Not Provided
Hospital Authority, Hong Kong
Baxter Healthcare Corporation
Principal Investigator: Chi Fai Ng, Dr Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP