Back to resultsStudy on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Primary Purpose
Prostatic Neoplasms, Bone Density
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zolderonic acid (Zometa)
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate cancer, bone mineral density
Eligibility Criteria
Inclusion Criteria:
- Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.
Exclusion Criteria:
- Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.
Patients who have:
- Serum creatinine levels >212 µmol/L (2.4 mg/dL).
- Creatinine clearance <50 ml/min.
- WBC <4.0x109/L, Hgb <10 g/dL, platelets <140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
Sites / Locations
- Department of Urology, Prince of Wales Hospital
Outcomes
Primary Outcome Measures
Bone mineral density of lumber spine
Bone mineral density of femoral neck
Secondary Outcome Measures
Change in serum creatinine, calcium, phosphate and alkaline phosphatase
Change in creatinine clearance
Full Information
NCT ID
NCT00489905
First Posted
June 20, 2007
Last Updated
October 22, 2013
Sponsor
Hospital Authority, Hong Kong
Collaborators
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00489905
Brief Title
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Official Title
Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Baxter Healthcare Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Bone Density
Keywords
prostate cancer, bone mineral density
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zolderonic acid (Zometa)
Primary Outcome Measure Information:
Title
Bone mineral density of lumber spine
Time Frame
12 months after administration of zolderonic acid
Title
Bone mineral density of femoral neck
Time Frame
12 months after administration of zolderonic acid
Secondary Outcome Measure Information:
Title
Change in serum creatinine, calcium, phosphate and alkaline phosphatase
Time Frame
From time of enrollment to 3 months after the last intervention
Title
Change in creatinine clearance
Time Frame
From time of enrollment to 3 months after the last intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.
Exclusion Criteria:
Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.
Patients who have:
Serum creatinine levels >212 µmol/L (2.4 mg/dL).
Creatinine clearance <50 ml/min.
WBC <4.0x109/L, Hgb <10 g/dL, platelets <140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fai Ng, Dr
Organizational Affiliation
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
We'll reach out to this number within 24 hrs