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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536653
First Posted: September 28, 2007
Last Update Posted: September 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wirral University Teaching Hospital NHS Trust
  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
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


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
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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536653


Locations
United Kingdom
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

ClinicalTrials.gov Identifier: NCT00536653     History of Changes
Other Study ID Numbers: 55/99
First Submitted: September 27, 2007
First Posted: September 28, 2007
Last Update Posted: September 28, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Osteoporosis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Androgens
Goserelin
Bicalutamide
Prolactin Release-Inhibiting Factors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists