The Effect of Denosumab on Bone Mass in Super Elderly Patients
2
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background: Denosumab is a potent antiresorptive drug leading to significant reduction in the risk of vertebral and non-vertebral fractures in postmenopausal osteoporosis. The effect of denosumab in super-elderly patients lacks data to date and few literature has proven the efficacy to this specific group. The purpose of this study was to determine the effectiveness and safety of denosumab in the super-elderly. Methods: We retrospectively evaluated 60 patients older than 80 with osteoporosis treated with denosumab. Patients were treated with denosumab every 6 months for 12 months 2017 to 2020. The primary endpoint was defined by the changes in bone mineral density (BMD) of 3 measurement sites: the lumbar spine, femoral neck, and total hip. Changes in bone turnover markers, serum calcium, serum phosphate, and 25-hydroxy-vitamin D were also observed. Results: All 60 patients were female, and the mean age was 83.9±3.1, from age 80 to 94. After 12 months of denosumab treatment, significant increases in BMD were observed; 3.02±2.74% for the lumbar spine (P=0.000), 3.10±6.90% for the femoral neck (P=0.005), and 2.89±5.80% for the total hip (P=0.002) The bone turnover marker C-terminal telopeptide of type I collagen and osteocalcin significantly declined after 12 months of treatment (-34.8±45.9%; P=0.002 and –35.5±38.9%; P=0.004 respectively). Symptomatic hypocalcemia and serious adverse drug reactions that required drug discontinuation were not observed during treatment. Conclusions: Denosumab is thought to be an anti-osteoporotic medication that is sufficiently effective and safe even for the super-elderly.
Abstract
Background: Denosumab is a potent antiresorptive drug leading to significant reduction in the risk of vertebral and non-vertebral fractures in postmenopausal osteoporosis. The effect of denosumab in super-elderly patients lacks data to date and few literature has proven the efficacy to this specific group. The purpose of this study was to determine the effectiveness and safety of denosumab in the super-elderly. Methods: We retrospectively evaluated 60 patients older than 80 with osteoporosis treated with denosumab. Patients were treated with denosumab every 6 months for 12 months 2017 to 2020. The primary endpoint was defined by the changes in bone mineral density (BMD) of 3 measurement sites: the lumbar spine, femoral neck, and total hip. Changes in bone turnover markers, serum calcium, serum phosphate, and 25-hydroxy-vitamin D were also observed. Results: All 60 patients were female, and the mean age was 83.9±3.1, from age 80 to 94. After 12 months of denosumab treatment, significant increases in BMD were observed; 3.02±2.74% for the lumbar spine (P=0.000), 3.10±6.90% for the femoral neck (P=0.005), and 2.89±5.80% for the total hip (P=0.002) The bone turnover marker C-terminal telopeptide of type I collagen and osteocalcin significantly declined after 12 months of treatment (-34.8±45.9%; P=0.002 and –35.5±38.9%; P=0.004 respectively). Symptomatic hypocalcemia and serious adverse drug reactions that required drug discontinuation were not observed during treatment. Conclusions: Denosumab is thought to be an anti-osteoporotic medication that is sufficiently effective and safe even for the super-elderly.
참고문헌 (35)
- "World population prospects 2019: Highlights (ST/ESA/SER.A/423)" (2019)[URL]
- Ettinger MP, "Aging bone and osteoporosis : strategies for preventing fractures in the elderly", Arch Intern Med, 163, pp.2237~2246 (2003)
- Kanis JA, "Ten year probabilities of osteoporotic fractures according to BMD and diagnostic thresholds", Osteoporos Int, 12, pp.989~995 (2001)
- Ström O, "Osteoporosis: burden, health care provision and opportunities in the EU: a report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA)", Arch Osteoporos, 6, pp.59~155 (2011)
- Wilkins CH, "Prevention of osteoporotic fractures in the elderly", Am J Med, 118, pp.1190~1195 (2005)
- Ray NF, "Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995 : report from the National Osteoporosis Foundation", J Bone Miner Res, 12, pp.24~35 (1997)
- Birge SJ, "Hip fracture", Clin Geriatr Med, 10, pp.589~609 (1994)
- Chrischilles EA, "A model of lifetime osteoporosis impact", Arch Intern Med, 151, pp.2026~2032 (1991)
- Center JR, "Osteoporosis medication and reduced mortality risk in elderly women and men", J Clin Endocrinol Metab, 96, pp.1006~1014 (2011)
- Cummings SR, "Denosumab for prevention of fractures in postmenopausal women with osteoporosis", N Engl J Med, 361, pp.756~765 (2009)
- Petranova T, "Medication-taking behaviour in Bulgarian women with postmenopausal osteoporosis treated with denosumab or monthly oral bisphosphonates", Arch Osteoporos, 13, pp.1~ (2017)
- Watts NB, "American association of clinical endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis : executive summary of recommendations", Endocr Pract, 16, pp.1016~1019 (2010)
- Khan SN, "Osteoporosis: therapeutic guidelines. Guidelines for practice management of osteoporosis", Clin Obstet Gynecol, 56, pp.694~702 (2013)
- Gurwitz JH, "Incidence and preventability of adverse drug events among older persons in the ambulatory setting", JAMA, 289, pp.1107~1116 (2003)
- Orwoll ES, "The rate of bone mineral loss in normal men and the effects of calcium and cholecalciferol supplementation", Ann Intern Med, 112, pp.29~34 (1990)
- Hannan MT, "Bone mineral density in elderly men and women : results from the Framingham osteoporosis study", J Bone Miner Res, 7, pp.547~553 (1992)
- Solomon DH, "Underuse of osteoporosis medications in elderly patients with fractures", Am J Med, 115, pp.398~400 (2003)
- Boonen S, "Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk", J Clin Endocrinol Metab, 96, pp.1727~1736 (2011)
- McClung MR, "Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis", J Bone Miner Res, 27, pp.211~218 (2012)
- Jönsson B, "Cost-effectiveness of denosumab for the treatment of postmenopausal osteoporosis", Osteoporos Int, 22, pp.967~982 (2011)
- Parthan A, "Cost effectiveness of denosumab versus oral bisphosphonates for postmenopausal osteoporosis in the US", Appl Health Econ Health Policy, 11, pp.485~497 (2013)
- Silverman S, "Denosumab for elderly men with osteoporosis : A cost-effectiveness analysis from the US payer perspective", J Osteoporos, 2015, pp.627631~ (2015)
- Wilcock A, "Denosumab : AHFS 92 : 24", J Pain Symptom Manage, 56, pp.295~301 (2018)
- Noble BS, "Identification of apoptotic changes in osteocytes in normal and pathological human bone", Bone, 20, pp.273~282 (1997)
- Jilka RL, "Increased bone formation by prevention of osteoblast apoptosis with parathyroid hormone", J Clin Invest, 104, pp.439~446 (1999)
- Bergot C, "Measurement of anisotropic vertebral trabecular bone loss during aging by quantitative image analysis", Calcif Tissue Int, 43, pp.143~149 (1988)
- McCalden RW, "Age-related changes in the tensile properties of cortical bone. The relative importance of changes in porosity, mineralization, and microstructure", J Bone Joint Surg Am, 75, pp.1193~1205 (1993)
- Rozman C, "Age-related variations of fat tissue fraction in normal human bone marrow depend both on size and number of adipocytes : a stereological study", Exp Hematol, 17, pp.34~37 (1989)
- Turnheim K, "When drug therapy gets old : pharmacokinetics and pharmacodynamics in the elderly", Exp Gerontol, 38, pp.843~853 (2003)
- Mallet L, "The challenge of managing drug interactions in elderly people", Lancet, 370, pp.185~191 (2007)
- Cusack BJ, "Pharmacokinetics in older persons", Am J Geriatr Pharmacother, 2, pp.274~302 (2004)
- Mangoni AA, "Age-related changes in pharmacokinetics and pharmacodynamics : basic principles and practical applications", Br J Clin Pharmacol, 57, pp.6~14 (2004)
- Hui SL, "Age and bone mass as predictors of fracture in a prospective study", J Clin Invest, 81, pp.1804~1809 (1988)
- De Laet CE, "Bone density and risk of hip fracture in men and women : cross sectional analysis", BMJ, 315, pp.221~225 (1997)
- Maher RL, "Clinical consequences of polypharmacy in elderly", Expert Opin Drug Saf, 13, pp.57~65 (2014)