TY - JOUR
T1 - Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy
T2 - Placebo-controlled double-blind study of estradiol and risedronate: N01C8
AU - Kearns, Ann E.
AU - Northfelt, Donald W.
AU - Dueck, Amylou C.
AU - Atherton, Pamela J.
AU - Dakhil, Shaker R.
AU - Rowland, Kendrith M.
AU - Fuloria, Jyotsna
AU - Flynn, Patrick J.
AU - Dentchev, Todor
AU - Loprinzi, Charles L.
N1 - This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35195, CA-63844, CA-35267, CA-35272, CA-35119, CA 124477, and CA-35431. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
This clinical trial was conducted by the North Central Cancer Treatment Group (NCCTG). It was approved by the National Cancer Institute prior to study initiation and by the local Institutional Review Boards. All patients provided informed consent per federal guidelines. This study was funded by the National Cancer Institute with supplemental funding from Proctor and Gamble.
PY - 2010/3
Y1 - 2010/3
N2 - Purpose: 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. Materials and 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.
AB - Purpose: 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. Materials and 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.
KW - Androgen deprivation therapy
KW - Estradiol
KW - Osteoporosis
KW - Prostate cancer
KW - Risedronate
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U2 - 10.1007/s00520-009-0655-x
DO - 10.1007/s00520-009-0655-x
M3 - Article
C2 - 19468757
AN - SCOPUS:77949273411
SN - 0941-4355
VL - 18
SP - 321
EP - 328
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 3
ER -