Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 1045-1052 |
| Number of pages | 8 |
| Journal | Fertility and Sterility |
| Volume | 92 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 2009 |
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All Science Journal Classification (ASJC) codes
- Obstetrics and Gynecology
- Reproductive Medicine
Cite this
Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. / Lindsay, Robert; Gallagher, John Christopher G.; Kagan, Risa; Pickar, James H.; Constantine, Ginger.
In: Fertility and Sterility, Vol. 92, No. 3, 09.2009, p. 1045-1052.Research output: Contribution to journal › Article
}
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, John Christopher G.
AU - Kagan, Risa
AU - Pickar, James H.
AU - Constantine, Ginger
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.
UR - http://www.scopus.com/inward/record.url?scp=69049083661&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=69049083661&partnerID=8YFLogxK
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 -