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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536653
• Other study ID #: 55/99
• Status: Completed
• Phase: N/A
• First received: September 27, 2007
• Last updated: September 27, 2007
• Start date: October 1999
• Est. completion date: January 2007

Study information

• Verified date: August 2007
• Source: Wirral University Teaching Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Wirral NHS Trust
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide and Calcium/ Vitamin D supplementation
Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
• 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
• LHRH agonists (Goserelin acetate)
3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Locations

Country	Name	City	State
United Kingdom	Wirral University Hospitals NHS Trust	Upton, Wirral	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Wirral University Teaching Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral Forearm bone mineral density		Over 7 years
Secondary	Fractures of the thoracolumbar spine		Over 7 years