Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer
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Purpose
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) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- Peripheral Forearm bone mineral density [ Time Frame: Over 7 years ]
- Fractures of the thoracolumbar spine [ Time Frame: Over 7 years ]
| Enrollment: | 618 |
| Study Start Date: | October 1999 |
| Study Completion Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Osteporosis Group
Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
|
Drug: Bicalutamide and Calcium/ Vitamin D supplementation
Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
|
|
Active Comparator: Osteopenia Group
Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
|
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
|
|
Active Comparator: Normal Group
Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists
|
Drug: LHRH agonists (Goserelin acetate)
3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)
|
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations| United Kingdom | |
| Wirral University Hospitals NHS Trust | |
| Upton, Wirral, Merseyside, United Kingdom, CH48 5PE | |
| Principal Investigator: | Nigel J Parr, MBBS, FRCS(Urol), MD | Wirral University Hospitals NHS Trust |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00536653 History of Changes |
| Other Study ID Numbers: | 55/99 |
| Study First Received: | September 27, 2007 |
| Last Updated: | September 27, 2007 |
| Health Authority: | United Kingdom: Wirral NHS Trust |
Keywords provided by Wirral University Teaching Hospital NHS Trust:
|
prostate cancer bone density osteoporosis androgen antagonists |
Additional relevant MeSH terms:
|
Osteoporosis Prostatic Neoplasms Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgen Antagonists Bicalutamide Androgens Calcium, Dietary |
Vitamin D Ergocalciferols Vitamins Goserelin Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hormones Bone Density Conservation Agents Micronutrients Growth Substances Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013