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

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ClinicalTrials.gov Identifier: NCT00520052
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 23, 2007
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment
Osteoporosis Drug: zoledronic acid

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
Study Start Date : August 2003
Study Completion Date : August 2005

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: LHRH Group
Patients on LHRH agonists and zoledronic acid
Drug: zoledronic acid
5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)
Other Name: zometa
Active Comparator: Bicalutamide Group
Patients on Bicalutamide and zoledronic acid
Drug: zoledronic acid
5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)
Other Name: zometa


Outcome Measures

Primary Outcome Measures :
  1. axial and peripheral bone mineral density [ Time Frame: over 3 years ]

Secondary Outcome Measures :
  1. serum and urine bone turnover markers [ Time Frame: over 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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): NCT00520052


Locations
United Kingdom
Wirral Hospitals Universirt NHS Trust
Upton, Wirral, Merseyside, United Kingdom, CH48 5PE
Sponsors and Collaborators
Wirral University Teaching Hospital NHS Trust
Novartis
Investigators
Principal Investigator: Nigel J Parr, MBBS, FRCS, MD Wirral Hospital University NHS Trust
More Information

ClinicalTrials.gov Identifier: NCT00520052     History of Changes
Other Study ID Numbers: 57/03
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: August 23, 2007
Last Verified: August 2007

Keywords provided by Wirral University Teaching Hospital NHS Trust:
bisphosphonates, prostate cancer, bone density, osteoporosis

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
Androgens
Zoledronic acid
Diphosphonates
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents