Effects of ultra-low dose hormone therapy on biochemical bone turnover markers in postmenopausal women: A randomized, placebo-controlled, double-blind trial

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dc.contributor.authorCosta-Paiva, Lucia
dc.contributor.authorO Wender, Maria Celeste
dc.contributor.authorMachado, Rogerio B
dc.contributor.authorPompei, Luciano M
dc.contributor.authorNahas, Eliana A [UNESP]
dc.contributor.authorNahas-Neto, Jorge [UNESP]
dc.contributor.authorDel Debbio, Sonia Y
dc.contributor.authorBadalotti, Mariangela
dc.contributor.authorCruz, Achilles M
dc.contributor.institutionUniversidade Estadual de Campinas (UNICAMP)
dc.contributor.institutionFederal University of Rio Grande do Sul–UFRGS
dc.contributor.institutionJundiai School of Medicine
dc.contributor.institutionABC School of Medicine
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionPaulista Center for Clinical Research-CEPIC
dc.contributor.institutionPUC-RS
dc.contributor.institutionLibbs Farmacêutica Ltda
dc.date.accessioned2023-03-01T21:05:17Z
dc.date.available2023-03-01T21:05:17Z
dc.date.issued2022-01-01
dc.description.abstractObjective: Evaluate the effects of ultra-low-dose hormone therapy (Ultra-LD HT) with 17β-estradiol 0.5 mg and norethisterone acetate 0.1 mg (E2 0.5/NETA 0.1) versus placebo on bone turnover markers (BTM) in postmenopausal women. Study Design: A multicenter, double-blind, randomized, placebo-controlled study was performed with 107 participants who received one tablet daily of E2 0.5/NETA 0.1 or placebo for 24-weeks. Bone formation markers-N-terminal propeptide of type I procollagen (PINP) and Bone-specific alkaline phosphatase (BSAP), and bone resorption markers-C-telopeptide of type I collagen (CTX-I) and N-telopeptide crosslinked of type I collagen (NTX) were assessed before and at 12 and 24-weeks of treatment. Results: Women treated with E2 0.5/NETA 0.1 had a significant reduction in the PINP marker from baseline (58.49 ± 21.12 μg/L) to week 12 (48.31 ± 20.99 μg/L) and week 24 (39.16 ± 16.50 μg/L). Placebo group, the PINP marker did not differ significantly. The analysis of the BSAP indicated a significant increase in the placebo group (13.8 ± 5.09 μg/L and 16.29 ± 4.3 μg/L, at baseline and week 24, respectively), whereas in the treatment group the values did not change. The analysis of the NTX marker showed a significant reduction only in the treatment group (43.21 ± 15.26 nM/mM and 33.89 ± 14.9 nM/mM, at baseline and week 24, respectively). CTX-I had a significant decrease in the treatment group from baseline (0.3 ± 0.16 ng/L) to week 12 (0.21 ± 0.14 ng/L) and week 24 (0.21 ± 0.12 ng/L). Conclusion: Women receiving E2 0.5/NETA 0.1 experienced reductions in bone resorption and formation markers, an expected effect during the anti-resorptive therapy, suggesting a protective bone effect with the Ultra-LD HT.en
dc.description.affiliationDepartment of Obstetrics and Gynecology Faculty of Medical Sciences State University of Campinas-UNICAMP Campinas
dc.description.affiliationDepartment of Obstetrics and Gynecology Federal University of Rio Grande do Sul–UFRGS
dc.description.affiliationDepartment of Gynecology and Obstetrics Jundiai School of Medicine
dc.description.affiliationDepartment of Gynecology and Obstetrics ABC School of Medicine
dc.description.affiliationDepartment of Gynecology and Obstetrics Botucatu School of Medicine UNESP-Sao Paulo State University
dc.description.affiliationPaulista Center for Clinical Research-CEPIC
dc.description.affiliationDepartment of Gynecology and Obstetrics PUC-RS
dc.description.affiliationDepartment of Clinical Research Libbs Farmacêutica Ltda
dc.description.affiliationUnespDepartment of Gynecology and Obstetrics Botucatu School of Medicine UNESP-Sao Paulo State University
dc.identifierhttp://dx.doi.org/10.1177/20533691221116769
dc.identifier.citationPost Reproductive Health.
dc.identifier.doi10.1177/20533691221116769
dc.identifier.issn2053-3705
dc.identifier.issn2053-3691
dc.identifier.scopus2-s2.0-85135604417
dc.identifier.urihttp://hdl.handle.net/11449/241483
dc.language.isoeng
dc.relation.ispartofPost Reproductive Health
dc.sourceScopus
dc.subjectbone mineral density
dc.subjectbone turnover marker
dc.subjectestrogen
dc.subjectmenopause
dc.subjectultra-low-dose hormone therapy
dc.titleEffects of ultra-low dose hormone therapy on biochemical bone turnover markers in postmenopausal women: A randomized, placebo-controlled, double-blind trialen
dc.typeArtigo
unesp.author.orcid0000-0002-9088-6700[1]

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