Preventing osteoporosis in symptomatic postmenopausal women

Menopause

Volumn 18, Issue 1, 2011, Pages 109-118

  Gallagher, J Christopher ^a   Levine, Jeffrey P ^b  

^a CREIGHTON UNIVERSITY MEDICAL CENTER   (United States)

^b ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

Author keywords

Bone mineral density; Fracture risk; Menopause; Osteoporosis; Prevention

Indexed keywords

ALENDRONIC ACID; BAZEDOXIFENE; BISPHOSPHONIC ACID DERIVATIVE; CONJUGATED ESTROGEN; CONJUGATED ESTROGEN PLUS MEDROXYPROGESTERONE ACETATE; DENOSUMAB; ESTRADIOL; ESTROGEN; GESTAGEN; IBANDRONIC ACID; LASOFOXIFENE; MEDROXYPROGESTERONE ACETATE; PLACEBO; RALOXIFENE; RISEDRONIC ACID; SELECTIVE ESTROGEN RECEPTOR MODULATOR; ZOLEDRONIC ACID;

ARTHRALGIA; BONE DENSITY; BONE NECROSIS; BONE PAIN; BONE TURNOVER; BRAIN ISCHEMIA; BREAST CANCER; CELLULITIS; CLINICAL TRIAL (TOPIC); DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ECZEMA; ENDOMETRIUM HYPERPLASIA; ESOPHAGITIS; ESTROGEN THERAPY; FEMUR NECK; GASTROINTESTINAL SYMPTOM; HEART ATRIUM FIBRILLATION; HORMONAL THERAPY; HOT FLUSH; HUMAN; HYSTERECTOMY; ISCHEMIC HEART DISEASE; JAW OSTEONECROSIS; LOW DRUG DOSE; LUMBAR SPINE; MASTALGIA; MENOPAUSAL SYNDROME; META ANALYSIS (TOPIC); MYALGIA; OSTEOLYSIS; POSTMENOPAUSE; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; THROMBOEMBOLISM; VAGINA BLEEDING; VERTEBRA FRACTURE;

DIPHOSPHONATES; ESTROGEN REPLACEMENT THERAPY; FEMALE; HUMANS; OSTEOPOROSIS, POSTMENOPAUSAL; SELECTIVE ESTROGEN RECEPTOR MODULATORS;

EID: 78651395974     PISSN: 10723714     EISSN: None     Source Type: Journal    
DOI: 10.1097/gme.0b013e3181e324a6     Document Type: Review

References (104)

1. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes 2005;3:47.
2. Vestergaard P, Hermann AP, Stilgren L, et al. Effects of 5 years of hormonal replacement therapy on menopausal symptoms and blood pressureVa randomised controlled study. Maturitas 2003;46:123-132.
3. Feldman BM, Voda A, Gronseth E. The prevalence of hot flash and associated variables among perimenopausal women. Res Nurs Health 1985;8:261-268.
4. Rödström K, Bengtsson C, Lissner L, Milsom I, Sundh V, Björkelund C. A longitudinal study of the treatment of hot flushes: the population study of women in Gothenburg during a quarter of a century. Menopause 2002;9:156-161.
5. Ohayon MM. Severe hot flashes are associated with chronic insomnia. Arch Intern Med 2006;166:1262-1268.
6. Erlik Y, Tataryn IV, Meldrum DR, Lomax P, Bajorek JG, Judd HL. Association of waking episodes with menopausal hot flushes. JAMA 1981;245:1741-1744.
7. Lu JKH, Judd HL. The neuroendocrine aspects of menopausal hot flashes. Prog Basic Clin Pharmacol 1991;6:83-99.
8. Politi MC, Schleinitz MD, Col NF. Revisiting the duration of vasomotor symptoms of menopause: a meta-analysis. J Gen Intern Med 2008;23: 1507-1513.
9. Loh FH. Use of hormone replacement therapy in the asymptomatic postmenopausal woman: what is the current evidence? Ann Acad Med Singapore 2003;32:605-609.
10. Versi E, Harvey MA, Cardozo L, Brincat M, Studd JW. Urogenital prolapse and atrophy at menopause: a prevalence study. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:107-110.
11. van Geelen JM, van de Weijer PH, Arnolds HT. Urogenital symptoms and resulting discomfort in non-institutionalized Dutch women aged 50-75 years. Int Urogynecol J Pelvic Floor Dysfunct 2000;11:9-14.
12. Oskay UY, Beji NK, Yalcin O. A study on urogenital complaints of postmenopausal women aged 50 and over. Acta Obstet Gynecol Scand 2005;84:72-78.
13. Haines CJ, Xing SM, Park KH, Holinka CF, Ausmanas MK. Prevalence of menopausal symptoms in different ethnic groups of Asian women and responsiveness to therapy with three doses of conjugated estrogens/ medroxyprogesterone acetate: the Pan-Asia Menopause (PAM) study. Maturitas 2005;52:264-276.
14. Weitzmann MN, Pacifici R. Estrogen deficiency and bone loss: an inflammatory tale. J Clin Invest 2006;116:1186-1194.
15. Dennison E, Cooper C. Epidemiology of osteoporotic fractures. Horm Res 2000;54:58-63.
16. NIH Consensus Development Panel. Osteoporosis prevention, diagnosis, and therapy. JAMA 2001;285:785-795.
17. National Osteoporosis Foundation. Fast facts. Available at: http://www. nof.org/osteoporosis/diseasefacts.htm. Accessed June 12, 2008.
18. Cummings SR, Browner WS, Bauer D, et al. Endogenous hormones and the risk of hip and vertebral fractures among older women. Study of Osteoporotic Fractures Research Group. N Engl J Med 1998;339: 733-738.
19. Caliri A, De Filippis L, Bagnato GL, Bagnato GF. Osteoporotic fractures: mortality and quality of life. Panminerva Med 2007;49:21-27.
20. Salaffi F, Cimmino MA, Malavolta N, et al. The burden of prevalent fractures on health-related quality of life in postmenopausal women with osteoporosis: the IMOF study. J Rheumatol 2007;34:1551-1560.
21. Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int 2005;16:S3-S7.
22. Gold DT. The nonskeletal consequences of osteoporotic fractures. Psychologic and social outcomes. Rheum Dis Clin North Am 2001;27: 255-262.
23. The North American Menopause Society. Management of osteoporosis in postmenopausal women: 2006 position statement of The North American Menopause Society. Menopause 2006;13:340-367.
24. MacLean C, Newberry S, Maglione M, et al. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med 2008; 148:197-213.
25. Raisz LG, Wiita B, Artis A, et al. Comparison of the effects of estrogen alone and estrogen plus androgen on biochemical markers of bone formation and resorption in postmenopausal women. J Clin Endocrinol Metab 1996;81:37-43.
26. Gambacciani M, Vacca F. Postmenopausal osteoporosis and hormone replacement therapy. Minerva Med 2004;95:507-520.
27. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 2001;286:2815-2822.
28. Writing Group for the PEPI Trial. Effects of hormone therapy on bone mineral density: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial. JAMA 1996;276:1389-1396.
29. Ettinger B, Genant HK, Steiger P, Madvig P. Low-dosage micronized 17A-estradiol prevents bone loss in postmenopausal women. Am J Obstet Gynecol 1992;166:479-488.
30. Wells G, Tugwell P, Shea B, et al. Meta-analyses of therapies for postmenopausal osteoporosis. V. Meta-analysis of the efficacy of hormone replacement therapy in treating and preventing osteoporosis in postmenopausal women. Endocr Rev 2002;23:529-539.
31. Gallagher JC. Effect of estrogen on bone. In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism, 5th ed. Washington, DC: American Society for Bone and Mineral Research, 2006:327-330.
32. Gallagher JC, Rapuri PB, Haynatzki G, Detter JR. Effect of discontinuation of estrogen, calcitriol, and the combination of both on bone density and bone markers. J Clin Endocrinol Metab 2002;87: 4914-4923.
33. Wasnich RD, Bagger YZ, Hosking DJ, et al. Changes in bone density and turnover after alendronate or estrogen withdrawal. Menopause 2004;11:622-630.
34. Bagger YZ, Tanko LB, Alexandersen P, et al. Two to three years of hormone replacement treatment in healthy women have long-term preventive effects on bone mass and osteoporotic fractures: the PERF study. Bone 2004;34:728-735.
35. Lindsay R, Gallagher JC, Kleerekoper M, Pickar JH. Bone response to treatment with lower doses of conjugated estrogens with and without medroxyprogesterone acetate in early postmenopausal women. Osteoporos Int 2005;16:372-379.
36. Lindsay R, Gallagher JC, Kleerekoper M, Pickar JH. Effect of lower doses of conjugated equine estrogens with and without medroxyprogesterone acetate on bone in early postmenopausal women. JAMA 2002;287:2668-2676.
37. Torgerson DJ, Bell-Syer SE. Hormone replacement therapy and prevention of nonvertebral fractures: a meta-analysis of randomized trials. JAMA 2001;285:2891-2897.
38. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004; 291:1701-1712.
39. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333.
40. Cauley JA, Robbins J, Chen Z, et al. Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative randomized trial. JAMA 2003;290:1729-1738.
41. Jackson RD, Wactawski-Wende J, LaCroix AZ, et al. Effects of conjugated equine estrogen on risk of fractures and BMD in postmenopausal women with hysterectomy: results from the Women's Health Initiative randomized trial. J Bone Miner Res 2006;21:817-828.
42. Rowan JP, Simon JA, Speroff L, Ellman H. Effects of low-dose norethindrone acetate plus ethinyl estradiol (0.5 mg/2.5 mg) in women with postmenopausal symptoms: updated analysis of three randomized, controlled trials. Clin Ther 2006;28:921-932.
43. Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev 2004:CD002978.
44. Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women's Health Initiative. Obstet Gynecol 2005;105:1063-1073.
45. Hulley S, Furberg C, Barrett-Connor E, et al. Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/ Progestin Replacement Study follow-up (HERS II). JAMA 2002;288: 58-66. (Pubitemid 34705519)
46. Stefanick ML, Anderson GL, Margolis KL, et al. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 2006;295: 1647-1657.
47. Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med 2003;349:523-534.
48. Stampfer MJ, Colditz GA, Willett WC, et al. Postmenopausal estrogen therapy and cardiovascular disease. Ten-year follow-up from the nurses' health study. N Engl J Med 1991;325:756-762.
49. Grodstein F, Manson JE, Stampfer MJ. Hormone therapy and coronary heart disease: the role of time since menopause and age at hormone initiation. J Womens Health (Larchmt) 2006;15:35-44. (Pubitemid 43192860)
50. Grodstein F, Manson JE, Colditz GA, Willett WC, Speizer FE, Stampfer MJ. A prospective, observational study of postmenopausal hormone therapy and primary prevention of cardiovascular disease. Ann Intern Med 2000;133:933-941.
51. Salpeter SR, Walsh JM, Greyber E, Salpeter EE. Brief report: coronary heart disease events associated with hormone therapy in younger and older women. A meta-analysis. J Gen Intern Med 2006;21: 363-366.
52. Hendrix SL, Wassertheil-Smoller S, Johnson KC, et al. Effects of conjugated equine estrogen on stroke in the Women's Health Initiative. Circulation 2006;113:2425-2434.
53. Pickar JH, Yeh IT, Wheeler JE, Cunnane MF, Speroff L. Endometrial effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate: two-year substudy results. Fertil Steril 2003;80: 1234-1240.
54. The North American Menopause Society. Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause 2008;15:584-602.
55. McClung MR. Bisphosphonates. Endocrinol Metab Clin North Am 2003;32:253-271.
56. Sambrook PN, Rodriguez JP, Wasnich RD, et al. Alendronate in the prevention of osteoporosis: 7-year follow-up. Osteoporos Int 2004;15: 483-488.
57. Ravn P, Bidstrup M, Wasnich RD, et al. Alendronate and estrogenprogestin in the long-term prevention of bone loss: four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial. Ann Intern Med 1999;131:935-942.
58. Ravn P, Weiss SR, Rodriguez-Portales JA, et al. Alendronate in early postmenopausal women: effects on bone mass during long-term treatment and after withdrawal. Alendronate Osteoporosis Prevention Study Group. J Clin Endocrinol Metab 2000;85:1492-1497.
59. McClung MR, Wasnich RD, Hosking DJ, et al. Prevention of postmenopausal bone loss: six-year results from the Early Postmenopausal Intervention Cohort Study. J Clin Endocrinol Metab 2004;89: 4879-4885.
60. Black DM, Schwartz AV, Ensrud KE, et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA 2006; 296:2927-2938.
61. Hooper MJ, Ebeling PR, Roberts AP, et al. Risedronate prevents bone loss in early postmenopausal women: a prospective randomized, placebocontrolled trial. Climacteric 2005;8:251-262.
62. Mortensen L, Charles P, Bekker PJ, Digennaro J, Johnston CC Jr. Risedronate increases bone mass in an early postmenopausal population: two years of treatment plus one year of follow-up. J Clin Endocrinol Metab 1998;83:396-402.
63. McClung MR, Wasnich RD, Recker R, et al. Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis. J Bone Miner Res 2004;19:11-18.
64. Tanko LB, Felsenberg D, Czerwinski E, et al. Oral weekly ibandronate prevents bone loss in postmenopausal women. J Intern Med 2003;254: 159-167.
65. Stakkestad JA, Benevolenskaya LI, Stepan JJ, et al. Intravenous ibandronate injections given every three months: a new treatment option to prevent bone loss in postmenopausal women. Ann Rheum Dis 2003; 62:969-975.
66. Grey A, Reid IR. Differences between the bisphosphonates for the prevention and treatment of osteoporosis. Ther Clin Risk Manag 2006; 2:77-86.
67. McClung MR, Bolognese MA, Sedarati F, Recker RR, Miller PD. Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. Bone 2009;44:418-422.
68. McClung M, Miller P, Recknor C, Mesenbrink P, Bucci-Rechtweg C, Benhamou CL. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol 2009;114:999-1007.
69. Strampel W, Emkey R, Civitelli R. Safety considerations with bisphosphonates for the treatment of osteoporosis. Drug Saf 2007;30: 755-763.
70. Blumentals WA, Harris ST, Cole RE, Huang L, Silverman SL. Risk of severe gastrointestinal events in women treated with monthly ibandronate or weekly alendronate and risedronate. Ann Pharmacother 2009; 43:577-585.
71. Binkley N, Martens MG, Silverman SL, et al. Improved GI tolerability with monthly ibandronate in women previously using weekly bisphosphonates. South Med J 2009;102:486-492.
72. Dalle CL, Bertoldo F, Lo CV. Evidences of safety and tolerability of the zoledronic acid 5 mg yearly in the post-menopausal osteoporosis: the HORIZON project. Reumatismo 2009;61:54-64.
73. Solomon DH, Rekedal L, Cadarette SM. Osteoporosis treatments and adverse events. Curr Opin Rheumatol 2009;21:363-368.
74. Edwards BJ, Hellstein JW, Jacobsen PL, Kaltman S, Mariotti A, Migliorati CA. Updated recommendations for managing the care of patients receiving oral bisphosphonate therapy: an advisory statement from the American Dental Association Council on Scientific Affairs. J Am Dent Assoc 2008;139:1674-1677.
75. Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007;22:1479-1491.
76. Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med 2010;362: 1761-1771.
77. Loke YK, Jeevanantham V, Singh S. Bisphosphonates and atrial fibrillation: systematic review and meta-analysis. Drug Saf 2009;32:219-228.
78. Henke BR, Heyer D. Recent advances in estrogen receptor modulators. Curr Opin Drug Discov Devel 2005;8:437-448.
79. Delmas PD, Bjarnason NH, Mitlak BH, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 1997;337: 1641-1647.
80. Johnston CC Jr, Bjarnason NH, Cohen FJ, et al. Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipid levels in early postmenopausal women: three-year data from 2 doubleblind, randomized, placebo-controlled trials. Arch Intern Med 2000;160: 3444-3450.
81. Jolly EE, Bjarnason NH, Neven P, et al. Prevention of osteoporosis and uterine effects in postmenopausal women taking raloxifene for 5 years. Menopause 2003;10:337-344.
82. Burshell AL, Song J, Dowsett SA, et al. Relationship between bone mass, invasive breast cancer incidence and raloxifene therapy in postmenopausal women with low bone mass or osteoporosis. Curr Med Res Opin 2008;24:807-813.
83. EVISTA (raloxifene hydrochloride) tablet for oral use [package insert]. Indianapolis, IN: Eli Lilly and Company, 2008.
84. Martino S, Disch D, Dowsett SA, Keech CA, Mershon JL. Safety assessment of raloxifene over eight years in a clinical trial setting. Curr Med Res Opin 2005;21:1441-1452.
85. Barrett-Connor E, Mosca L, Collins P, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 2006;355:125-137. (Pubitemid 44050394)
86. Collins P, Mosca L, Geiger MJ, et al. Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for the Heart trial: results of subgroup analyses by age and other factors. Circulation 2009;119:922-930.
87. Aldrighi JM, Quail DC, Levy-Frebault J, et al. Predictors of hot flushes in postmenopausal women who receive raloxifene therapy. Am J Obstet Gynecol 2004;191:1979-1988.
88. Arun B, Anthony M, Dunn B. The search for the ideal SERM. Expert Opin Pharmacother 2002;3:681-691.
89. Miller PD, Chines AA, Christiansen C, et al. Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study. J Bone Miner Res 2008;23:525-535.
90. Silverman SL, Christiansen C, Genant HK, et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res 2008;23:1923-1934.
91. Komm BS. A new approach to menopausal therapy: the tissue selective estrogen complex. Reprod Sci 2008;15:984-992.
92. Kharode Y, Bodine PV, Miller CP, Lyttle CR, Komm BS. The pairing of a selective estrogen receptor modulator, bazedoxifene, with conjugated estrogens as a new paradigm for the treatment of menopausal symptoms and osteoporosis prevention. Endocrinology 2008; 149:6084-6091.
93. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril 2009;92:1045-1052.
94. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause 2009;16:1116-1124.
95. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/ conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril 2009;92:1025-1038.
96. Pickar JH, Yeh I-T, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril 2009;92:1018-1024.
97. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/ conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril 2009;92:1039-1044.
98. McClung MR, Siris E, Cummings S, et al. Prevention of bone loss in postmenopausal women treated with lasofoxifene compared with raloxifene. Menopause 2006;13:377-386.
99. Cummings SR, Ensrud K, Delmas PD, et al. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med 2010;362:686-696.
100. McClung MR, Lewiecki EM, Cohen SB, et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006; 354:821-831.
101. Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361:756-765.
102. Caufriez A. Hormonal replacement therapy (HRT) in postmenopause: a reappraisal. Ann Endocrinol (Paris) 2007;68:241-250.
103. The North American Menopause Society. Estrogen and progestogen use in peri- and postmenopausal women: March 2007 position statement of The North American Menopause Society. Menopause 2007;14:1-17.
104. World Health Organization Collaborating Centre for Metabolic Bone Diseases. FRAXA WHO Fracture Risk Assessment Tool. Available at: http://www.shef.ac.uk/FRAX/. Accessed October 28, 2009.