Effects of Bazedoxifene/Vitamin D Combination Therapy on Serum Vitamin D Levels and Bone Turnover Markers in Postmenopausal Women with Osteopenia: A Randomized Controlled Trial
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Background: This study aimed to evaluate the effectiveness of bazedoxifene/vitamin D combination therapy in preventing osteoporosis in postmenopausal women with osteopenia. Methods: This was an open-label, multicenter randomized-controlled, phase 4 clinical trial. Women between ages of 55 and 70 years in 9 medical tertiary centers in Korea were enrolled and assigned into 2 groups: an experiment group and a control group. The experimental group received bazedoxifene 20 mg/vitamin D 800 IU tablets for 6 months, and the control group received calcium 100 mg/vitamin D 1,000 IU tablets for 6 months. Results: A total of 142 patients (70 in the experimental group and 72 in the control group) were included. The least-square mean±standard error of change in propeptide of type I collagen after 3 months was -6.87±2.56% in the experimental group and 1.22±2.54% in the control group. After 6 months, it was -21.07±2.75% in the experimental group and 1.26±2.71% in the control group. The difference between the 2 groups was -22.33% (P<0.01). The change of C-terminal telopeptide was -12.55±4.05% in the experimental group and 11.02±4.03% in the control group after 3 months. It was -22.0±3.95% and 10.20±3.89, respectively, after 6 months. The difference between the 2 groups was -32.21% (P<0.01) after 6 months. There was no significant difference in adverse events between the 2 groups. Conclusions: The osteoporosis preventive effect and safety of administering bazedoxifene/vitamin D combination pill were confirmed in postmenopausal women who needed osteoporosis prevention.
Abstract
Background: This study aimed to evaluate the effectiveness of bazedoxifene/vitamin D combination therapy in preventing osteoporosis in postmenopausal women with osteopenia. Methods: This was an open-label, multicenter randomized-controlled, phase 4 clinical trial. Women between ages of 55 and 70 years in 9 medical tertiary centers in Korea were enrolled and assigned into 2 groups: an experiment group and a control group. The experimental group received bazedoxifene 20 mg/vitamin D 800 IU tablets for 6 months, and the control group received calcium 100 mg/vitamin D 1,000 IU tablets for 6 months. Results: A total of 142 patients (70 in the experimental group and 72 in the control group) were included. The least-square mean±standard error of change in propeptide of type I collagen after 3 months was -6.87±2.56% in the experimental group and 1.22±2.54% in the control group. After 6 months, it was -21.07±2.75% in the experimental group and 1.26±2.71% in the control group. The difference between the 2 groups was -22.33% (P<0.01). The change of C-terminal telopeptide was -12.55±4.05% in the experimental group and 11.02±4.03% in the control group after 3 months. It was -22.0±3.95% and 10.20±3.89, respectively, after 6 months. The difference between the 2 groups was -32.21% (P<0.01) after 6 months. There was no significant difference in adverse events between the 2 groups. Conclusions: The osteoporosis preventive effect and safety of administering bazedoxifene/vitamin D combination pill were confirmed in postmenopausal women who needed osteoporosis prevention.
참고문헌 (38)
- Peck WA, "Consensus development conference : diagnosis, prophylaxis, and treatment of osteoporosis", Am J Med, 94, pp.646~650 (1993)[DOI]
- 안승희, "Osteoporosis and Osteoporotic Fracture Fact Sheet in Korea", 대한골대사학회지, 27(4), pp.281~290 (2020), 대한골대사학회
- Reginster JY, "Osteoporosis : a still increasing prevalence", Bone, 38, pp.S4~S9 (2006)[DOI]
- 이영균, "Epidemiology of Osteoporosis and Osteoporotic Fractures in South Korea", Endocrinology and Metabolism, 28(2), pp.90~93 (2013), 대한내분비학회
- 김하영, "Healthcare Costs of Osteoporotic Fracture in Korea: Information from the National Health Insurance Claims Database, 2008-2011", 대한골대사학회지, 24(2), pp.125~133 (2017), 대한골대사학회[DOI]
- 박현주, "Bone Mineral Density Screening Interval and Transition to Osteoporosis in Asian Women", Endocrinology and Metabolism, 37(3), pp.506~512 (2022), 대한내분비학회[DOI]
- Cauley JA, "Serum 25-hydroxyvitamin D concentrations and risk for hip fractures", Ann Intern Med, 149, pp.242~250 (2008)[DOI]
- Bischoff-Ferrari HA, "Dietary calcium and serum 25-hydroxyvitamin D status in relation to BMD among U.S. adults", J Bone Miner Res, 24, pp.935~942 (2009)[DOI]
- Holick MF, "Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline", J Clin Endocrinol Metab, 96, pp.1911~1930 (2011)[DOI]
- Ross AC, "The national academies collection: reports funded by national institutes of health", pp.NBK56070~ (2011), National Academies Press
- Anna Han, "Position Statement: Vitamin D Intake to Prevent Osteoporosis and Fracture in Adults", 대한골대사학회지, 29(4), pp.205~215 (2022), 대한골대사학회
- Halpern R, "The association of adherence to osteoporosis therapies with fracture, all-cause medical costs, and all-cause hospitalizations: a retrospective claims analysis of female health plan enrollees with osteoporosis", J Manag Care Pharm, 17, pp.25~39 (2011)[DOI]
- Sampalis JS, "Long-term impact of adherence to oral bisphosphonates on osteoporotic fracture incidence", J Bone Miner Res, 27, pp.202~210 (2012)[DOI]
- Du LP, "The impact of fixed-dose combination versus free-equivalent combination therapies on adherence for hypertension : a meta-analysis", J Clin Hypertens(Greenwich), 20, pp.902~907 (2018)[DOI]
- Tsioufis K, "Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature", J Hypertens, 38, pp.1016~1028 (2020)[DOI]
- Herdman M, "Development and preliminary testing of the new five-level version of EQ-5D(EQ-5D-5L)", Qual Life Res, 20, pp.1727~1736 (2011)[DOI]
- Kim SH, "The EQ-5D-5L valuation study in Korea", Qual Life Res, 25, pp.1845~1852 (2016)[DOI]
- Xu L, "Efficacy and safety of bazedoxifene in postmenopausal Asian women", Osteoporos Int, 22, pp.559~565 (2011)[DOI]
- Bachmann G, "Effects of bazedoxifene in nonflushing postmenopausal women : a randomized phase 2 trial", Menopause, 18, pp.508~514 (2011)[DOI]
- Miller PD, "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, 23, pp.525~535 (2008)[DOI]
- Black DM, "Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis", N Engl J Med, 356, pp.1809~1822 (2007)[DOI]
- Liang BC, "Intravenous zoledronic acid 5 mg on bone turnover markers and bone mineral density in east China subjects with newly diagnosed osteoporosis : A 24-month clinical study", Orthop Surg, 9, pp.103~109 (2017)[DOI]
- Cummings SR, "Denosumab for prevention of fractures in postmenopausal women with osteoporosis", N Engl J Med, 361, pp.756~765 (2009)[DOI]
- Eastell R, "Treatment-related changes in bone turnover and fracture risk reduction in clinical trials of antiresorptive drugs : Proportion of treatment effect explained", J Bone Miner Res, 36, pp.236~243 (2021)[DOI]
- Morris HA, "Clinical usefulness of bone turnover marker concentrations in osteoporosis", Clin Chim Acta, 467, pp.34~41 (2017)[DOI]
- Johansson H, "A meta-analysis of reference markers of bone turnover for prediction of fracture", Calcif Tissue Int, 94, pp.560~567 (2014)[DOI]
- Jacques RM, "Relationship of changes in total hip bone mineral density to vertebral and nonvertebral fracture risk in women with postmenopausal osteoporosis treated with once-yearly zoledronic acid 5 mg : the HORIZON-Pivotal Fracture Trial(PFT)", J Bone Miner Res, 27, pp.1627~1634 (2012)[DOI]
- Bruyère O, "Relationships between changes in bone mineral density or bone turnover markers and vertebral fracture incidence in patients treated with bazedoxifene", Calcif Tissue Int, 91, pp.244~249 (2012)[DOI]
- Vergnaud P, "Undercarboxylated osteocalcin measured with a specific immunoassay predicts hip fracture in elderly women : the EPIDOS Study", J Clin Endocrinol Metab, 82, pp.719~724 (1997)[DOI]
- 박소영, "Position Statement on the Use of Bone Turnover Markers for Osteoporosis Treatment", 대한골대사학회지, 26(4), pp.213~224 (2019), 대한골대사학회
- Christiansen C, "Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis", BMC Musculoskelet Disord, 11, pp.130~ (2010)[DOI]
- de Villiers TJ, "Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial", Osteoporos Int, 22, pp.567~576 (2011)[DOI]
- Davies GC, "Adverse events reported by postmenopausal women in controlled trials with raloxifene", Obstet Gynecol, 93, pp.558~565 (1999)[DOI]
- Goldstein SR, "Not all SERMs are created equal", Menopause, 13, pp.325~327 (2006)[DOI]
- Arslanca T, "The relationship between vitamin D and vasomotor symptoms during the postmenopausal period", Clin Lab, 66 (2020)[DOI]
- 김경민, "Calcium and Vitamin D Supplementations: 2015 Position Statement of the Korean Society for Bone and Mineral Research", 대한골대사학회지, 22(4), pp.143~149 (2015), 대한골대사학회
- Madar AA, "Effect of vitamin D(3)-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway", Bone Rep, 2, pp.82~88 (2015)[DOI]
- Aloia J, "The relative influence of calcium intake and vitamin D status on serum parathyroid hormone and bone turnover biomarkers in a double-blind, placebo-controlled parallel group, longitudinal factorial design", J Clin Endocrinol Metab, 95, pp.3216~3224 (2010)[DOI]
