Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489905
• Other study ID #: CRE-2005.137-T
• Secondary ID: HARECCTR0500010
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: October 22, 2013
• Start date: April 2005
• Est. completion date: May 2008

Study information

• Verified date: October 2013
• Source: Hospital Authority, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2008
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Density
• Prostatic Neoplasms

Intervention

Drug:
• Zolderonic acid (Zometa)

Locations

Country	Name	City	State
China	Department of Urology, Prince of Wales Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density of lumber spine		12 months after administration of zolderonic acid
Primary	Bone mineral density of femoral neck		12 months after administration of zolderonic acid
Secondary	Change in serum creatinine, calcium, phosphate and alkaline phosphatase		From time of enrollment to 3 months after the last intervention
Secondary	Change in creatinine clearance		From time of enrollment to 3 months after the last intervention

External Links

•   HAREC Clinical Trial Registry