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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Bicalutamide and Calcium/ Vitamin D supplementation; Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation; Drug: LHRH agonists (Goserelin acetate)

• Registration Number: NCT00536653
• Lead Sponsor: Wirral University Teaching Hospital NHS Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-10
• Study Completion: 2007-01
• Status Verified: 2007-08
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Last Update Submitted: 2007-09-27
• Study First Posted: 2007-09-28
• Last Update Posted: 2007-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 618

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteporosis Group	Bicalutamide and Calcium/ Vitamin D supplementation	Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
Osteopenia Group	LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation	Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
Normal Group	LHRH agonists (Goserelin acetate)	Patients with a presenting T score \> -1.0(normal BMD), treated with LHRH agonists

Primary Outcome Measures

Name	Time	Method
Peripheral Forearm bone mineral density	Over 7 years

Secondary Outcome Measures

Name	Time	Method
Fractures of the thoracolumbar spine	Over 7 years

Trial Locations

Locations (1)

Wirral University Hospitals NHS Trust; 🇬🇧 Upton, Wirral, Merseyside, United Kingdom