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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
Est. primary completion date
Accepts healthy volunteers
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


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
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