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Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer

NCT ID: NCT00520052

Last Updated: 2007-08-23

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-08-31

Brief Summary

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The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer

Detailed Description

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Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.

The study will also involve monitoring serum and urine bone turnover markers.

Conditions

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Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LHRH Group

Patients on LHRH agonists and zoledronic acid

Group Type ACTIVE_COMPARATOR

zoledronic acid

Intervention Type DRUG

5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)

Bicalutamide Group

Patients on Bicalutamide and zoledronic acid

Group Type ACTIVE_COMPARATOR

zoledronic acid

Intervention Type DRUG

5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)

Interventions

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zoledronic acid

5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)

Intervention Type DRUG

Other Intervention Names

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zometa

Eligibility Criteria

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Inclusion Criteria

* patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)

Exclusion Criteria

* patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Wirral University Teaching Hospital NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Nigel J Parr, MBBS, FRCS, MD

Role: PRINCIPAL_INVESTIGATOR

Wirral Hospital University NHS Trust

Locations

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Wirral Hospitals Universirt NHS Trust

Upton, Wirral, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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57/03

Identifier Type: -

Identifier Source: org_study_id