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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00536653
Enrollment
618
Registered
2007-09-28
Start date
1999-10-31
Completion date
2007-01-31
Last updated
2007-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

prostate cancer, bone density, osteoporosis, androgen antagonists

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.

Interventions

DRUGBicalutamide and Calcium/ Vitamin D supplementation

Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily

DRUGLHRH 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

DRUGLHRH agonists (Goserelin acetate)

3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Sponsors

Wirral University Teaching Hospital NHS Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Peripheral Forearm bone mineral densityOver 7 years

Secondary

MeasureTime frame
Fractures of the thoracolumbar spineOver 7 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026