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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer
Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.
The study will also involve monitoring serum and urine bone turnover markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LHRH Group | Active Comparator | Patients on LHRH agonists and zoledronic acid |
|
| Bicalutamide Group | Active Comparator | Patients on Bicalutamide and zoledronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | 5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| axial and peripheral bone mineral density | over 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| serum and urine bone turnover markers | over 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel J Parr, MBBS, FRCS, MD | Wirral Hospital University NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wirral Hospitals Universirt NHS Trust | Upton, Wirral | Merseyside | CH48 5PE | United Kingdom |
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|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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