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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bicalutamide and Calcium/ Vitamin D supplementation
LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation
LHRH agonists (Goserelin acetate)
Sponsored by
Wirral University Teaching Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring prostate cancer, bone density, osteoporosis, androgen antagonists

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wirral University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Osteporosis Group

Osteopenia Group

Normal Group

Arm Description

Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD

Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD

Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists

Outcomes

Primary Outcome Measures

Peripheral Forearm bone mineral density

Secondary Outcome Measures

Fractures of the thoracolumbar spine

Full Information

First Posted
September 27, 2007
Last Updated
September 27, 2007
Sponsor
Wirral University Teaching Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00536653
Brief Title
Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wirral University Teaching Hospital NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
prostate cancer, bone density, osteoporosis, androgen antagonists

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
618 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteporosis Group
Arm Type
Active Comparator
Arm Description
Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
Arm Title
Osteopenia Group
Arm Type
Active Comparator
Arm Description
Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
Arm Title
Normal Group
Arm Type
Active Comparator
Arm Description
Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists
Intervention Type
Drug
Intervention Name(s)
Bicalutamide and Calcium/ Vitamin D supplementation
Intervention Description
Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
Intervention Type
Drug
Intervention Name(s)
LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation
Intervention Description
3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily
Intervention Type
Drug
Intervention Name(s)
LHRH agonists (Goserelin acetate)
Intervention Description
3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)
Primary Outcome Measure Information:
Title
Peripheral Forearm bone mineral density
Time Frame
Over 7 years
Secondary Outcome Measure Information:
Title
Fractures of the thoracolumbar spine
Time Frame
Over 7 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel J Parr, MBBS, FRCS(Urol), MD
Organizational Affiliation
Wirral University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wirral University Hospitals NHS Trust
City
Upton, Wirral
State/Province
Merseyside
ZIP/Postal Code
CH48 5PE
Country
United Kingdom

12. IPD Sharing Statement

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

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