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

Wirral University Teaching Hospital NHS Trust

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Bicalutamide and Calcium/ Vitamin D supplementation; Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation; Drug: LHRH agonists (Goserelin acetate)

Study type: Interventional

Funder types: Other

Identifiers

NCT00536653

55/99

Details and patient eligibility

About

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.

Full 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.

Enrollment: 618 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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618 participants in 3 patient groups

Osteporosis Group

Active Comparator group

Description:

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

Treatment:

Drug: Bicalutamide and Calcium/ Vitamin D supplementation

Osteopenia Group

Active Comparator group

Description:

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

Treatment:

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

Normal Group

Active Comparator group

Description:

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

Treatment:

Drug: LHRH agonists (Goserelin acetate)