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Sponsored by: |
Wirral University Teaching Hospital NHS Trust |
Information provided by: | Wirral University Teaching Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00536653 |
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.
Condition | Intervention |
Osteoporosis |
Drug: Bicalutamide and Calcium/ Vitamin D supplementation Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation Drug: LHRH agonists (Goserelin acetate) |
MedlinePlus related topics: | Cancer Fractures Minerals Osteoporosis Prostate Cancer |
Drug Information available for: | Calcium gluconate Vitamin D Ergocalciferol Goserelin Bicalutamide Gonadorelin Gonadorelin hydrochloride LH-RH |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 618 |
Study Start Date: | October 1999 |
Study Completion Date: | January 2007 |
Arms | Assigned Interventions |
Osteporosis Group: Active Comparator
Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
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Drug: Bicalutamide and Calcium/ Vitamin D supplementation
Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
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Osteopenia Group: Active Comparator
Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
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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
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Normal Group: Active Comparator
Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists
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Drug: LHRH agonists (Goserelin acetate)
3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)
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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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Merseyside | |||||
Wirral University Hospitals NHS Trust | |||||
Upton, Wirral, Merseyside, United Kingdom, CH48 5PE |
Wirral University Teaching Hospital NHS Trust |
Principal Investigator: | Nigel J Parr, MBBS, FRCS(Urol), MD | Wirral University Hospitals NHS Trust |
Study ID Numbers: | 55/99 |
First Received: | September 27, 2007 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00536653 |
Health Authority: | United Kingdom: Wirral NHS Trust |
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