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

October 22, 2013 updated by: Hospital Authority, Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Department of Urology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone mineral density of lumber spine
Time Frame: 12 months after administration of zolderonic acid
12 months after administration of zolderonic acid
Bone mineral density of femoral neck
Time Frame: 12 months after administration of zolderonic acid
12 months after administration of zolderonic acid

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum creatinine, calcium, phosphate and alkaline phosphatase
Time Frame: From time of enrollment to 3 months after the last intervention
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
From time of enrollment to 3 months after the last intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Chi Fai Ng, Dr, Department of Surgery, Division of Urology, The Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2005.137-T
  • HARECCTR0500010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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