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

This study has been completed.

Sponsored by: Wirral University Teaching Hospital NHS Trust
Information provided by: Wirral University Teaching Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00536653
  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)

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   

U.S. FDA Resources

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

Further study details as provided by Wirral University Teaching Hospital NHS Trust:

Primary Outcome Measures:
  • Peripheral Forearm bone mineral density [ Time Frame: Over 7 years ]

Secondary Outcome Measures:
  • 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
Osteporosis Group: Active Comparator
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
Osteopenia Group: Active Comparator
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
Normal Group: Active Comparator
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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536653

Locations
United Kingdom, Merseyside
Wirral University Hospitals NHS Trust    
      Upton, Wirral, Merseyside, United Kingdom, CH48 5PE

Sponsors and Collaborators
Wirral University Teaching Hospital NHS Trust

Investigators
Principal Investigator:     Nigel J Parr, MBBS, FRCS(Urol), MD     Wirral University Hospitals NHS Trust    
  More Information


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

Keywords provided by Wirral University Teaching Hospital NHS Trust:
prostate cancer  
bone density  
osteoporosis  
androgen antagonists  

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Fractures, Bone
Ergocalciferols
Goserelin
Osteoporosis
Bone Diseases, Metabolic
Urogenital Neoplasms
Genital Diseases, Male
Bone Diseases
Vitamin D
Musculoskeletal Diseases
Bicalutamide
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Growth Substances
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on October 24, 2008




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