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Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

NCT ID: NCT00536653

Last Updated: 2007-09-28

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

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2007-01-31

Brief Summary

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The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

Detailed Description

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Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.

Conditions

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Osteoporosis

Keywords

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prostate cancer bone density osteoporosis androgen antagonists

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Osteporosis Group

Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD

Group Type ACTIVE_COMPARATOR

Bicalutamide and Calcium/ Vitamin D supplementation

Intervention Type DRUG

Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily

Osteopenia Group

Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD

Group Type ACTIVE_COMPARATOR

LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation

Intervention Type DRUG

3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily

Normal Group

Patients with a presenting T score \> -1.0(normal BMD), treated with LHRH agonists

Group Type ACTIVE_COMPARATOR

LHRH agonists (Goserelin acetate)

Intervention Type DRUG

3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Interventions

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Bicalutamide and Calcium/ Vitamin D supplementation

Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily

Intervention Type DRUG

LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation

3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily

Intervention Type DRUG

LHRH agonists (Goserelin acetate)

3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

Exclusion Criteria

* Previous systemic therapy for prostate cancer
* Patients with any illness or medication that would affect bone and mineral metabolism
* Severe hepatic or renal insufficiency
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wirral University Teaching Hospital NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Nigel J Parr, MBBS, FRCS(Urol), MD

Role: PRINCIPAL_INVESTIGATOR

Wirral University Hospitals NHS Trust

Locations

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Wirral University Hospitals NHS Trust

Upton, Wirral, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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55/99

Identifier Type: -

Identifier Source: org_study_id