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CompletedNCT00520052Updated Aug 23, 2007

Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer

An interventional study of zoledronic acid in Osteoporosis, sponsored by Wirral University Teaching Hospital NHS Trust. Completed at 1 site in United Kingdom. Open to male participants. Per ClinicalTrials.gov, last updated 2007-08-23.

Sponsored by Wirral University Teaching Hospital NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Non-randomized
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Osteoporosis

Keywords

  • bisphosphonates, prostate cancer, bone density, osteoporosis
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 58 is close to the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Wirral University Teaching Hospital NHS Trust is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    LHRH Group

    Patients on LHRH agonists and zoledronic acid

    Drug: zoledronic acid

  • Active comparator
    Bicalutamide Group

    Patients on Bicalutamide and zoledronic acid

    Drug: zoledronic acid

Interventions

  • Drugzoledronic acid

    5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)

    Also known as: zometa

06

What researchers measure

Primary outcomes

  1. axial and peripheral bone mineral density

    Time frame: over 3 years

Secondary outcomes

  1. serum and urine bone turnover markers

    Time frame: over 1 year

07

Study locations

1 site
  • Wirral Hospitals Universirt NHS Trust
    Upton, Wirral, Merseyside CH48 5PE, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520052
Lead sponsor
Wirral University Teaching Hospital NHS Trust
Collaborators
Novartis
First posted
Aug 23, 2007
Start date
Aug 2003
Completion
Aug 2005
Last update
Aug 23, 2007

Study contacts

Nigel J Parr, MBBS, FRCS, MD
principal investigator · Wirral Hospital University NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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