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
Overview
- Phase
- Not Applicable
- Intervention
- Bicalutamide and Calcium/ Vitamin D supplementation
- Conditions
- Osteoporosis
- Sponsor
- Wirral University Teaching Hospital NHS Trust
- Enrollment
- 618
- Locations
- 1
- Primary Endpoint
- Peripheral Forearm bone mineral density
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Osteporosis Group
Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
Intervention: Bicalutamide and Calcium/ Vitamin D supplementation
Osteopenia Group
Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
Intervention: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation
Normal Group
Patients with a presenting T score \> -1.0(normal BMD), treated with LHRH agonists
Intervention: LHRH agonists (Goserelin acetate)
Outcomes
Primary Outcomes
Peripheral Forearm bone mineral density
Time Frame: Over 7 years
Secondary Outcomes
- Fractures of the thoracolumbar spine(Over 7 years)