Randomized controlled trial of zoledronic acid to prevent bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer.
OBJECTIVE
A multicenter double-blind, randomized, placebo controlled clinical trial was performed to assess the effect of zoledronic acid, a potent new bisphosphonate, on bone mineral density during androgen deprivation therapy for nonmetastatic prostate cancer.


METHODS
Men with M0 (no distant metastases) prostate cancer beginning androgen deprivation therapy were randomly assigned to receive 4 mg. zoledronic acid or placebo intravenously every 3 months for 1 year. The primary efficacy variable was the percent change from baseline to 1 year in bone mineral density of the lumbar spine as measured by dual energy x-ray absorptiometry.


RESULTS
A total of 106 men were enrolled in the trial. Mean bone mineral density in the lumbar spine increased by 5.6% in men receiving zoledronic acid and decreased by 2.2% in those given placebo (mean difference 7.8%, 95% confidence interval 5.6%-10.0%, p <0.001). Mean bone mineral density of the femoral neck, trochanter and total hip also increased in the zoledronic acid group and decreased in the placebo group. Zoledronic acid was well tolerated.


CONCLUSIONS
Zoledronic acid increases bone mineral density in the hip and spine during androgen deprivation therapy for nonmetastatic prostate cancer.
Smith
Matthew R
MR
Massachusetts General Hospital, Boston, Massachusetts, USA.
Eastham
James
J
Gleason
Donald M
DM
Shasha
Daniel
D
Tchekmedyian
Simon
S
Zinner
Norman
N
D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D004164:Diphosphonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D007987:Gonadotropin-Releasing Hormone / Q000009:adverse effects / Q000819:agonists / Q000627:therapeutic use; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D009919:Orchiectomy / Q000009:adverse effects; D010024:Osteoporosis / Q000209:etiology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000628:therapy*; D000077211:Zoledronic Acid
D000726:Androgen Antagonists; D004164:Diphosphonates; D007093:Imidazoles; D007987:Gonadotropin-Releasing Hormone; D000077211:Zoledronic Acid