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

Lindsay, Robert; Gallagher, J. Christopher; Kagan, Risa; Pickar, James H.; Constantine, Ginger D.

doi:10.1016/j.fertnstert.2009.02.093

Cited by 207 publications

(131 citation statements)

References 21 publications

(20 reference statements)

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“…In substudy II, total hip BMD was higher in all bazedoxifene/CEE doses compared with placebo at both months 12 and 24, and for femoral neck BMD, the same superiority of bazedoxifene/CEE doses over placebo was true except for bazedoxifene (40 mg)/CEEs (0.45 mg) at month 12 [198]. Additionally, at both time points, median percent changes from baseline in serum osteocalcin and Ctelopeptide were significantly greater with all bazedoxifene/ CEE doses than with placebo (p <0.001).…”

Section: Tissue Selective Estrogen Complex (Tsec)mentioning

confidence: 82%

“…In substudy I, mean percent increases in total hip BMD were significantly higher from baseline to month 24 with bazedoxifene (10 mg)/CEEs (0.625 or 0.45 mg) and bazedoxifene (20 mg)/CEEs (0.625 mg) compared with raloxifene. Further, total hip BMD was significantly higher with all doses of bazedoxifene/CEE doses from baseline at months 12 and 24 compared with decreases observed with placebo [198].In substudy II, total hip BMD was higher in all bazedoxifene/CEE doses compared with placebo at both months 12 and 24, and for femoral neck BMD, the same superiority of bazedoxifene/CEE doses over placebo was true except for bazedoxifene (40 mg)/CEEs (0.45 mg) at month 12 [198]. Additionally, at both time points, median percent changes from baseline in serum osteocalcin and Ctelopeptide were significantly greater with all bazedoxifene/ CEE doses than with placebo (p <0.001).…”

mentioning

confidence: 81%

“…An approach, termed the tissueselective estrogen complex, blends tissue-selective activities of a SERM with an estrogen. For example, bazedoxifene in combination with conjugated equine estrogens (CEE) has been studied for the treatment of both hot flushes and vulvar vaginal atrophy, with positive results on both menopausal symptoms [196,197].One study involving 3397 women either 1-5 years post menopause or >5 years post menopause enrolled in the Osteoporosis Prevention I and II Substudies aimed to evaluate the efficacy of the tissue-selective estrogen complex bazedoxifene/CEE to prevent osteoporosis [198]. The study used bazedoxifene (10, 20, or 40 mg) with CEEs (0.625 or 0.45 mg), raloxifene (60 mg), or placebo, and was administered daily for 2 years.…”

mentioning

confidence: 99%

“…There are several novel agents being evaluated to address hot flashes [207][208][209][210]. Bazedoxifene has been shown to maintain or increase BMD, reduce bone turnover, and decrease the risk of new vertebral fracture in postmenopausal women without evidence of endometrial or breast stimulation in large, prospective phase III studies [196][197][198]. In the global placebo-and active-controlled osteoporosis treatment study, bazedoxifene showed a significant reduction in nonvertebral fracture risk in a subgroup of more than 1,700 women at higher risk for fracture relative to both placebo and raloxifene.…”

mentioning

confidence: 99%

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A New Therapeutic Paradigm for Breast Cancer Exploiting Low Dose Estrogen-Induced Apoptosis

Jordan¹

2013

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Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. REPORT DATEJune PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Georgetown University PERFORMING ORGANIZATION REPORT NUMBERWashington, DC 20057-0004 SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR'S ACRONYM(S) U.S. Army Medical Research and Materiel CommandFort Detrick, Maryland 21702-5012 SPONSOR/MONITOR'S REPORT NUMBER(S) DISTRIBUTION / AVAILABILITY STATEMENTApproved for Public Release; Distribution Unlimited SUPPLEMENTARY NOTES ABSTRACTThe purpose of the CoE is to discover the molecular mechanisms and the modulation estrogen-induced apoptosis. The laboratory research project is focused on genomics and proteomics with a current focus on molecular interrogation to decipher mechanisms that may be applied to aid patient treatment. In parallel, but not supported by the CoE, is a pilot clinical study of estrogen-induced apoptosis in patients with metastatic breast cancer, that have had repeated cycles of successful antihormone therapy, but have subsequently failed and relapsed. A new low dose protocol is being completed. The molecular pharmacology laboratory of the Principle Investigator (PI) is advancing in all areas originally designated in the grant, e.g. a description of the time dependent changes in estrogen-responsive growth and apoptosis in model cell lines, an evaluation and description of the early proteomic pathways associated with estrogen-induced apoptosis dependent on the estrogen receptor (ER) co-activator AIB1 (SRC-3), the critical importance of the shape of the ER complex, the mechanism of c-Src activity that mediates apoptosis and the genomic spectrum of our endocrine resistant cell lines to define cell sensitivity to estrogen-induced apoptosis. We have discovered and described all the stages of the development of estrogen induced apoptosis through the (mitochondrial) pathway that becomes reinforced by the extrinsic (death receptor) pathway. We have correlated rises in reactive oxygen species (ROS) with intrinsic apoptosis and through RNAseq analysis, identified AP-1 (cFos and cJun) as the critical mediators for estrogen-induced apoptosis. SUBJECT TERMS-Gene expression micr...

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Section: Tissue Selective Estrogen Complex (Tsec)mentioning

confidence: 82%

mentioning

confidence: 81%

mentioning

confidence: 99%

mentioning

confidence: 99%

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A New Therapeutic Paradigm for Breast Cancer Exploiting Low Dose Estrogen-Induced Apoptosis

Jordan¹

2013

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“…3 Most pharmacological agents used in the prevention and treatment of osteoporosis reduce bone resor ption or delay the total rate of bone turnover. For the prevention of fractures are applied: inhibitors of the activity of osteoclastsbisphosphonates Rizedronate and Zoledronate, 4 selective estrogen receptor modulators Bazedoxifene 5 and Lasofoxifene 6 parathyroid hormone, 7 Strontium ranelate 8 and antiresorptive agent Denosumab -a human monoclonal antibody IgG 2 .…”

Section: Introductionmentioning

confidence: 99%

Application of TLC-Densitometry for Analysis of Estradiol Hemihydrate in Dosage Forms.

Tsvetkova¹,

Obreshkova²,

Ivanova³

et al. 2016

IJPER

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The aim of current study was the application of validated TLC-densitometric method for identification and determination of Estradiol hemihydrate in dosage forms. The applied TLC conditions were: Silicagel G 60 F 254 glass plates; mobile phase: chloroform : acetone = 90 : 10 v/v, migration distance of mobile phase: 120 mm, UV-detection at  = 254 nm. All of the experimental results for the content of Estradiol hemihydrate correspond to the respective confidence interval: Estrofem

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Estrogens, Selective Estrogen Receptor Modulators, and Tissue‐Selective Estrogen Complex

Villiers

2018

Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism

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

Cited by 207 publications

References 21 publications

A New Therapeutic Paradigm for Breast Cancer Exploiting Low Dose Estrogen-Induced Apoptosis

A New Therapeutic Paradigm for Breast Cancer Exploiting Low Dose Estrogen-Induced Apoptosis

Application of TLC-Densitometry for Analysis of Estradiol Hemihydrate in Dosage Forms.

Estrogens, Selective Estrogen Receptor Modulators, and Tissue‐Selective Estrogen Complex

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