Back to resultsFrequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring bisphosphonates, prostate cancer, bone density, osteoporosis
Eligibility Criteria
Inclusion Criteria:
- patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)
Exclusion Criteria:
- patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.
Sites / Locations
- Wirral Hospitals Universirt NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LHRH Group
Bicalutamide Group
Arm Description
Patients on LHRH agonists and zoledronic acid
Patients on Bicalutamide and zoledronic acid
Outcomes
Primary Outcome Measures
axial and peripheral bone mineral density
Secondary Outcome Measures
serum and urine bone turnover markers
Full Information
NCT ID
NCT00520052
First Posted
August 22, 2007
Last Updated
August 22, 2007
Sponsor
Wirral University Teaching Hospital NHS Trust
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00520052
Brief Title
Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
Official Title
Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wirral University Teaching Hospital NHS Trust
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer
Detailed Description
Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.
The study will also involve monitoring serum and urine bone turnover markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
bisphosphonates, prostate cancer, bone density, osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LHRH Group
Arm Type
Active Comparator
Arm Description
Patients on LHRH agonists and zoledronic acid
Arm Title
Bicalutamide Group
Arm Type
Active Comparator
Arm Description
Patients on Bicalutamide and zoledronic acid
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Other Intervention Name(s)
zometa
Intervention Description
5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)
Primary Outcome Measure Information:
Title
axial and peripheral bone mineral density
Time Frame
over 3 years
Secondary Outcome Measure Information:
Title
serum and urine bone turnover markers
Time Frame
over 1 year
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)
Exclusion Criteria:
patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel J Parr, MBBS, FRCS, MD
Organizational Affiliation
Wirral Hospital University NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wirral Hospitals Universirt NHS Trust
City
Upton, Wirral
State/Province
Merseyside
ZIP/Postal Code
CH48 5PE
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
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