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

NCT ID: NCT00489905

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Neoplasms Bone Density

Keywords

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prostate cancer bone mineral density

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zolderonic acid (Zometa)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Chi Fai Ng, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Division of Urology, The Chinese University of Hong Kong

Locations

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Department of Urology, Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HARECCTR0500010

Identifier Type: -

Identifier Source: secondary_id

CRE-2005.137-T

Identifier Type: -

Identifier Source: org_study_id