Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy: placebo-controlled double-blind study of estradiol and risedronate: N01C8.
OBJECTIVE
The purpose of this study is to test the ability of risedronate and estradiol, alone or in combination, to prevent bone loss associated with androgen deprivation therapy in men with prostate cancer.


METHODS
This is a randomized placebo-controlled trial of risedronate and estradiol, alone or in combination, in men with prostate cancer receiving androgen deprivation therapy. The primary outcome was change in hip bone mineral density at 1 year.


RESULTS
No statistical difference was found among the groups for bone mineral density changes. The only side effects of note were increased gynecomastia and breast tenderness associated with estrogen therapy. The study was limited by poor accrual and subsequent lack of statistical power.


CONCLUSIONS
Men receiving androgen deprivation therapy for prostate cancer are at risk for bone loss and should receive appropriate bone density monitoring and preventive advice about calcium, vitamin D, exercise, and fall prevention. Prescription drugs proven in this patient population should be used when the risk of fracture is high.
Kearns
Ann E
AE
Mayo Clinic Rochester, 200 First Street, SW, Rochester, MN 55905, USA.
Northfelt
Donald W
DW
Dueck
Amylou C
AC
Atherton
Pamela J
PJ
Dakhil
Shaker R
SR
Rowland
Kendrith M
KM
Fuloria
Jyotsna
J
Flynn
Patrick J
PJ
Dentchev
Todor
T
Loprinzi
Charles L
CL
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004958:Estradiol / Q000627:therapeutic use*; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006177:Gynecomastia / Q000139:chemically induced; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000139:chemically induced* / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D000068296:Risedronic Acid
D050071:Bone Density Conservation Agents; D007987:Gonadotropin-Releasing Hormone; D004958:Estradiol; D000068296:Risedronic Acid; D012968:Etidronic Acid