Bone Density, Prostatic Neoplasms
Conditions
Keywords
prostate cancer, bone mineral density
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.
Interventions
DRUGZolderonic acid (Zometa)
Sponsors
Baxter Healthcare Corporation
Hospital Authority, Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density of lumber spine | 12 months after administration of zolderonic acid |
| Bone mineral density of femoral neck | 12 months after administration of zolderonic acid |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum creatinine, calcium, phosphate and alkaline phosphatase | From time of enrollment to 3 months after the last intervention |
| Change in creatinine clearance | From time of enrollment to 3 months after the last intervention |
Countries
China
Outcome results
None listed