Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women

Robert Lindsay, John Christopher G. Gallagher, Risa Kagan, James H. Pickar, Ginger Constantine

Research output: Contribution to journalArticle

187 Citations (Scopus)

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 languageEnglish
Pages (from-to)1045-1052
Number of pages8
JournalFertility and Sterility
Volume92
Issue number3
DOIs
StatePublished - Sep 2009

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Conjugated (USP) Estrogens
Osteoporosis
Estrogens
Placebos
Bone Density
Spine
Hip
Postmenopause
Postmenopausal Osteoporosis
Bone Remodeling
Osteocalcin
Menopause
Tablets
Outpatients
Outcome Assessment (Health Care)
Bone and Bones
bazedoxifene
Raloxifene Hydrochloride
Therapeutics

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 journalArticle

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