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

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, June 2008

First Received: June 20, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong Baxter Healthcare Corporation
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00489905

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Minerals Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

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
Estimated 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

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

Contacts

Contact: Annie YF Wong

(852) 2632 2501

anniewong@surgery.cuhk.edu.hk

Locations

China
Department of Urology, Prince of Wales Hospital	Recruiting
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:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CRE-2005.137-T, HARECCTR0500010
Study First Received:	June 20, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00489905 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

prostate cancer
bone mineral density

Study placed in the following topic categories:

Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male
Bone Density Conservation Agents

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Zoledronic acid
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs

Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009