NCT00536653

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

Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: Wirral University Teaching Hospital NHS Trust · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Bicalutamide and Calcium/ Vitamin D supplementation	Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
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
DRUG	LHRH agonists (Goserelin acetate)	3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Timeline

• Start date: 1999-10-01
• Completion: 2007-01-01
• First posted: 2007-09-28
• Last updated: 2007-09-28

Locations

1 site across 1 country: United Kingdom