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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00489905
First received: June 20, 2007
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Prostatic Neoplasms
Bone Density
Drug: Zolderonic acid (Zometa)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: April 2005
Study Completion Date: May 2008
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489905

Locations
China
Department of Urology, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Baxter Healthcare Corporation
Investigators
Principal Investigator: Chi Fai Ng, Dr Department of Surgery, Division of Urology, The Chinese University of Hong Kong
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00489905     History of Changes
Other Study ID Numbers: CRE-2005.137-T, HARECCTR0500010
Study First Received: June 20, 2007
Last Updated: October 22, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
prostate cancer
bone mineral density

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Androgens
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 29, 2014