TY - JOUR
T1 - Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women
AU - Lindsay, Robert
AU - Gallagher, J. Christopher
AU - Kagan, Risa
AU - Pickar, James H.
AU - Constantine, Ginger
N1 - Funding Information:
Supported by Wyeth Research, Collegeville, Pennsylvania.
Funding Information:
R.L. received research grants from Wyeth, Lilly, and Proctor & Gamble and is a speaker for Proctor & Gamble, sanofi-aventis, Lilly, Wyeth, GlaxoSmithKline and Novartis. J.C.G. received research grants from Wyeth, Pfizer, Organon, Zelos, Amgen, and Deltanoids; is a consultant for Wyeth, Pfizer, GlaxoSmithKline, Organon, and Amgen; and is a speaker for Wyeth, Roche, and Proctor & Gamble. R.K. received research grants from Proctor & Gamble, Aventis, Lilly, Novartis, Amgen, Boehringer Ingelheim, Dopomed, Roche, and Wyeth; is a consultant for Merck, Proctor & Gamble, GlaxoSmithKline, Roche, Lilly, Upsher-Smith, and Wyeth; and is a speaker for GlaxoSmithKline, Roche, Merck, Novogyne, Bayer and Lilly. J.P. is an employee of Wyeth Pharmaceuticals. G.C. has nothing to disclose.
Copyright:
Copyright 2009 Elsevier B.V., All rights reserved.
PY - 2009/9
Y1 - 2009/9
N2 - Objective: To evaluate the efficacy of the tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE), for postmenopausal osteoporosis prevention. Design: Multicenter, randomized, double-blind, placebo- and active-controlled, phase 3 trial (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting: Outpatient clinical study. Patient(s): Women (n = 3,397) more than 5 years and 1-5 years postmenopause were enrolled in the Osteoporosis Prevention I and II Substudies, respectively. Intervention(s): Single tablets of BZA (10, 20, or 40 mg) each with CE (0.625 or 0.45 mg), raloxifene (60 mg), or a placebo taken daily for 2 years. Main Outcome Measure(s): The primary outcome for both substudies was change in bone mineral density of the lumbar spine; bone mineral density was also measured at the hip. Result(s): In both substudies, bone mineral density increased significantly more with all BZA/CE doses compared with placebo at the lumbar spine and total hip, and for most BZA/CE doses compared with raloxifene at the lumbar spine. Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene. Conclusion(s): BZA/CE combinations decreased bone turnover and bone loss in postmenopausal women at increased risk for osteoporosis.
AB - Objective: To evaluate the efficacy of the tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE), for postmenopausal osteoporosis prevention. Design: Multicenter, randomized, double-blind, placebo- and active-controlled, phase 3 trial (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting: Outpatient clinical study. Patient(s): Women (n = 3,397) more than 5 years and 1-5 years postmenopause were enrolled in the Osteoporosis Prevention I and II Substudies, respectively. Intervention(s): Single tablets of BZA (10, 20, or 40 mg) each with CE (0.625 or 0.45 mg), raloxifene (60 mg), or a placebo taken daily for 2 years. Main Outcome Measure(s): The primary outcome for both substudies was change in bone mineral density of the lumbar spine; bone mineral density was also measured at the hip. Result(s): In both substudies, bone mineral density increased significantly more with all BZA/CE doses compared with placebo at the lumbar spine and total hip, and for most BZA/CE doses compared with raloxifene at the lumbar spine. Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene. Conclusion(s): BZA/CE combinations decreased bone turnover and bone loss in postmenopausal women at increased risk for osteoporosis.
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U2 - 10.1016/j.fertnstert.2009.02.093
DO - 10.1016/j.fertnstert.2009.02.093
M3 - Article
C2 - 19635616
AN - SCOPUS:69049083661
VL - 92
SP - 1045
EP - 1052
JO - Fertility and Sterility
JF - Fertility and Sterility
SN - 0015-0282
IS - 3
ER -