{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:28:38Z","timestamp":1790634518346,"version":"4.1.0"},"reference-count":25,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2022,10,26]],"date-time":"2022-10-26T00:00:00Z","timestamp":1666742400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Menopausal hormone deficiency can exert multiple effects on various organs. Vulvovaginal atrophy (VVA) is among the most widespread and disabling post-menopausal disorder. Hormonal changes can also result in a markedly increased rate of bone mineral density (BMD) loss. Ospemifene (OSP) is an SERM indicated to treat vulvar and vaginal atrophy (VVA) in postmenopausal women. This study evaluates the long-term effects of ospemifene therapy on bone metabolism and bone mineral parameters in postmenopausal women reporting VVA\/GSM. Methods: Women reporting VVA symptoms were included. Bone health profile was investigated in 61 subjects treated with OSP (OSPG) (60 mg\/day) and compared with a control group (CG) (n = 67) over 12 months. Results: In the CG, BMD and T-score statistically decreased at the femoral neck (FN), total femur (TF), and lumbar spine (L1\u2013L4). In the OSPG, BMD decreased significantly at FN but tended to remain stable at TF and L1\u2013L4. No changes were observed in bone mineral markers after one year in either group, except BAP, which decreased in OSPG. Conclusions: Long-term OSP treatment improves bone mineral markers at TF and LS and slows bone loss at FN compared to the control group. Overall, OSP exerts a protective effect on bone loss in healthy menopausal women with VVA.<\/jats:p>","DOI":"10.3390\/jcm11216316","type":"journal-article","created":{"date-parts":[[2022,10,26]],"date-time":"2022-10-26T09:59:37Z","timestamp":1666778377000},"page":"6316","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Effect of Ospemifene on Densitometric and Plasma Bone Metabolism Biomarkers in Postmenopausal Women Reporting Vulvar and Vaginal Atrophy (VVA)"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5081-1253","authenticated-orcid":false,"given":"Silvia","family":"Maffei","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Endocrinology and Metabolism, Gynaecological and Cardiovascular Endocrinology and Osteoporosis Unit, \u201cGabriele Monasterio\u201d Foundation and Italian National Research Council (CNR) Pisa, 56124 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3330-3238","authenticated-orcid":false,"given":"Letizia","family":"Guiducci","sequence":"additional","affiliation":[{"name":"National Research Council, Institute of Clinical Physiology, Via Moruzzi 1, 56124 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,10,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"561","DOI":"10.3389\/fendo.2019.00561","article-title":"Addressing Vulvovaginal Atrophy (VVA)\/Genitourinary Syndrome of Menopause (GSM) for Healthy Aging in Women","volume":"10","author":"Nappi","year":"2019","journal-title":"Front. Endocrinol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/0378-5122(95)00956-6","article-title":"Urogenital ageing: An old problem newly recognized","volume":"22","author":"Bachmann","year":"1995","journal-title":"Maturitas"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1002\/jbmr.534","article-title":"Bone mineral density loss in relation to the final menstrual period in a multiethnic cohort: Results from the Study of Women\u2019s Health Across the Nation (SWAN)","volume":"27","author":"Greendale","year":"2011","journal-title":"J. Bone Miner. Res."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1002\/jbmr.4444","article-title":"Characteristics of Long-Term Femoral Neck Bone Loss in Postmenopausal Women: A 25-Year Follow-Up","volume":"37","author":"Moilanen","year":"2022","journal-title":"J. Bone Miner. Res."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/8756-3282(96)00102-0","article-title":"Low bone mass and fast rate of bone loss at menopause: Equal risk factors for future fracture: A 15-year follow-up study","volume":"19","author":"Riis","year":"1996","journal-title":"Bone"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"S57","DOI":"10.1016\/S0378-5122(99)00064-X","article-title":"Moderation of the daily dose of HRT: Prevention of osteoporosis","volume":"33","author":"Gallagher","year":"1999","journal-title":"Maturitas"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"480","DOI":"10.1097\/gme.0b013e3181c1ac01","article-title":"Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: Results from a pivotal phase 3 study","volume":"17","author":"Bachmann","year":"2010","journal-title":"Menopause"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"617","DOI":"10.2147\/IJWH.S110035","article-title":"Clinical update on the use of Ospemifene in the treatment of severe symptomatic vulvar and vaginal atrophy","volume":"8","author":"Palacios","year":"2016","journal-title":"Int. J. Womens Health"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1016\/j.steroids.2014.07.012","article-title":"Ospemifene: A first-in-class, non-hormonal selective estrogen receptor modulator approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy","volume":"90","author":"DeGregorio","year":"2014","journal-title":"Steroids"},{"key":"ref_10","unstructured":"(2022, October 20). European Public Assessment Report European Medicines Agency. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/smop-initial\/chmp-summary-positive-opinion-senshio_en.pdf."},{"key":"ref_11","unstructured":"European Medicines Agency (2022, October 20). Senshio Public Assessment Report (03\/2022) Annex I Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/senshio#assessment-history-section."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1","DOI":"10.17303\/jwhg.2021.8.301","article-title":"Effect of Ospemifene on Cardiometabolic Risk in Postmenopausal Women Reporting Vulvo and Vaginal Atrophy (VVA): Results of a 12-Month Prospective Study","volume":"8","author":"Maffei","year":"2021","journal-title":"J. Women\u2019s Health Gynecol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"173","DOI":"10.3109\/13697137.2013.834493","article-title":"Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy","volume":"17","author":"Goldstein","year":"2014","journal-title":"Climacteric"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"638","DOI":"10.1097\/GME.0000000000000619","article-title":"Effects of Ospemifene on bone parameters including clinical biomarkers in postmenopausal women","volume":"23","author":"Constantine","year":"2016","journal-title":"Menopause"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1080\/09513590410001672197","article-title":"Effects of Ospemifene, a novel SERM, on biochemical markers of bone turnover in healthy postmenopausal women","volume":"18","author":"Komi","year":"2004","journal-title":"Gynecol. Endocrinol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"314","DOI":"10.1007\/s00774-006-0689-9","article-title":"Effects of Ospemifene and Raloxifene on biochemical markers of bone turnover in postmenopausal women","volume":"24","author":"Komi","year":"2006","journal-title":"J. Bone Miner. Metab."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"368","DOI":"10.1007\/BF01622200","article-title":"Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: Synopsis of a WHO report. WHO Study Group","volume":"4","author":"Kanis","year":"1994","journal-title":"Osteoporos. Int."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"E654","DOI":"10.1210\/jc.2012-3651","article-title":"Serum sex steroid levels and longitudinal changes in bone density in relation to the final menstrual period","volume":"98","author":"Crandall","year":"2013","journal-title":"J. Clin. Endocrinol. Metab."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"695","DOI":"10.1016\/j.ogc.2018.07.012","article-title":"Bone Health During the Menopause Transition and Beyond","volume":"45","author":"Karlamangla","year":"2018","journal-title":"Obstet. Gynecol. Clin. N. Am."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"442","DOI":"10.1080\/13697137.2019.1631789","article-title":"Effects of Ospemifene on bone in postmenopausal women","volume":"22","author":"Altomare","year":"2019","journal-title":"Climacteric"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"809","DOI":"10.1210\/endo.141.2.7342","article-title":"Selective estrogenic effects of a novel triphenylethylene compound, FC1271a, on bone, cholesterol level, and reproductive tissues in intact and ovariectomized rats","volume":"141","author":"Qu","year":"2000","journal-title":"Endocrinology"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1273","DOI":"10.1016\/j.steroids.2013.09.003","article-title":"Tissue selectivity of Ospemifene: Pharmacologic profile and clinical implications","volume":"78","author":"Kangas","year":"2013","journal-title":"Steroids"},{"key":"ref_23","unstructured":"World Health Organization (1994). Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: Report of a WHO study group (meeting held in Rome from Jun 22\u201325, 1992). World Health Organ. Tech. Rep. Ser., 843, 1\u2013129."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1080\/09513590.2021.1970740","article-title":"Vaginal health, endometrial thickness and changes in bone markers in postmenopausal women after 6 months of treatment with ospemifene in real clinical practice","volume":"38","author":"Lafuente","year":"2022","journal-title":"Gynecol. Endocrinol."},{"key":"ref_25","unstructured":"Coe, F.L., and Favus, M.J. (1992). Embriology anatomy and microstructure of Bone. Disorders of Bone and Mineral Metabolism, Raven Press. Available online: https:\/\/www.semanticscholar.org\/paper\/Embryology-anatomy-and-microstructure-of-bone-Recker\/a1d3ede7b06ea20160c18ec44be24031536968c6#paper-header."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/21\/6316\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:03:27Z","timestamp":1760144607000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/21\/6316"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,26]]},"references-count":25,"journal-issue":{"issue":"21","published-online":{"date-parts":[[2022,11]]}},"alternative-id":["jcm11216316"],"URL":"https:\/\/doi.org\/10.3390\/jcm11216316","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,26]]}}}