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

Not Applicable
Completed
Conditions
Prostatic Neoplasms
Bone Density
Registration Number
NCT00489905
Lead Sponsor
Hospital Authority, Hong Kong
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
24
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Bone mineral density of femoral neck12 months after administration of zolderonic acid
Bone mineral density of lumber spine12 months after administration of zolderonic acid
Secondary Outcome Measures
NameTimeMethod
Change in creatinine clearanceFrom time of enrollment to 3 months after the last intervention
Change in serum creatinine, calcium, phosphate and alkaline phosphataseFrom time of enrollment to 3 months after the last intervention

Trial Locations

Locations (1)

Department of Urology, Prince of Wales Hospital

🇨🇳

Hong Kong, China

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