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

September 27, 2007 updated by: Wirral University Teaching Hospital NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

618

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral Forearm bone mineral density
Time Frame: Over 7 years
Over 7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Fractures of the thoracolumbar spine
Time Frame: Over 7 years
Over 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wirral University Teaching Hospital NHS Trust

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2007

Last Update Submitted That Met QC Criteria

September 27, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55/99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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