The efficacy of denosumab in Korean male patients with osteoporosis
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background/Aims: Despite the prominence of denosumab as the number one prescribed anti-osteoporosis drug in Korea, the effects of denosumab in male osteoporosis patients were not researched sufficiently. Moreover, concerns on rebound vertebral fractures associated with poor denosumab adherence exist. Methods: We retrospectively evaluated 147 Korean male osteoporosis patients treated with denosumab. After 12 months of treatment, 60 patients were lost during follow-up, and eight were excluded due to missing data. Out of the initial 147 patients, 79 were considered eligible for the analysis of the efficacy of denosumab. 54 patients were initially drug-naïve, and 25 had previously received bisphosphonate therapy. Results: In 54 drug-naïve patients, significant increases in bone mineral density (BMD) were observed in all measurement sites: 5.2% ± 3.7% in the lumbar spine, 2.3% ± 2.8% in the femoral neck, and 1.9% ± 2.8% in the total hip (p < 0.01, respectively). Trabecular bone score showed an increase of 0.5% ± 5.8% in drug-naïve patients. Likewise, in 25 patients with previous bisphosphonate treatment, increase in BMD were observed as well: 4.8% ± 3.5% in the lumbar spine, 1.4% ± 3.6% in the femoral neck, and 0.8% ± 2.1% in the total hip (p < 0.01, p = 0.06, p = 0.06, respectively). Significant declines of –55.1% ± 31.8% in C-terminal telopeptide of type 1 collagen (CTX), and –62.9% ± 21.3% in total procollagen 1 N-terminal propeptide (P1NP), in drug-naïve patients; and –37.7% ± 41.5%, in CTX and –55.4% ± 30.1%, in P1NP in patients with previous bisphosphonate treatment were exhibited after 12 months of treatment. The adherence rates of the second and third dosing schedules were 79.9% and 56.8%, respectively. Conclusions: Our study indicates that denosumab is effective in increasing BMD in Korean osteoporosis males regardless of prior bisphosphonate treatment.
Abstract
Background/Aims: Despite the prominence of denosumab as the number one prescribed anti-osteoporosis drug in Korea, the effects of denosumab in male osteoporosis patients were not researched sufficiently. Moreover, concerns on rebound vertebral fractures associated with poor denosumab adherence exist. Methods: We retrospectively evaluated 147 Korean male osteoporosis patients treated with denosumab. After 12 months of treatment, 60 patients were lost during follow-up, and eight were excluded due to missing data. Out of the initial 147 patients, 79 were considered eligible for the analysis of the efficacy of denosumab. 54 patients were initially drug-naïve, and 25 had previously received bisphosphonate therapy. Results: In 54 drug-naïve patients, significant increases in bone mineral density (BMD) were observed in all measurement sites: 5.2% ± 3.7% in the lumbar spine, 2.3% ± 2.8% in the femoral neck, and 1.9% ± 2.8% in the total hip (p < 0.01, respectively). Trabecular bone score showed an increase of 0.5% ± 5.8% in drug-naïve patients. Likewise, in 25 patients with previous bisphosphonate treatment, increase in BMD were observed as well: 4.8% ± 3.5% in the lumbar spine, 1.4% ± 3.6% in the femoral neck, and 0.8% ± 2.1% in the total hip (p < 0.01, p = 0.06, p = 0.06, respectively). Significant declines of –55.1% ± 31.8% in C-terminal telopeptide of type 1 collagen (CTX), and –62.9% ± 21.3% in total procollagen 1 N-terminal propeptide (P1NP), in drug-naïve patients; and –37.7% ± 41.5%, in CTX and –55.4% ± 30.1%, in P1NP in patients with previous bisphosphonate treatment were exhibited after 12 months of treatment. The adherence rates of the second and third dosing schedules were 79.9% and 56.8%, respectively. Conclusions: Our study indicates that denosumab is effective in increasing BMD in Korean osteoporosis males regardless of prior bisphosphonate treatment.
참고문헌 (36)
- Cummings SR, "Epidemiology and outcomes of osteoporotic fractures", Lancet, 359, pp.1761~1767 (2002)
- Hallberg I, "Health-related quality of life after osteoporotic fractures", Osteoporos Int, 15, pp.834~841 (2004)
- Randell AG, "Deterioration in quality of life following hip fracture : a prospective study", Osteoporos Int, 11, pp.460~466 (2000)
- "Osteoporosis and osteoporotic fracture fact sheet 2019" (2019)[URL]
- Johnell O, "An estimate of the worldwide prevalence and disability associated with osteoporotic fractures", Osteoporos Int, 17, pp.1726~1733 (2006)
- Gullberg B, "World-wide projections for hip fracture", Osteoporos Int, 7, pp.407~413 (1997)
- Haentjens P, "Meta-analysis : excess mortality after hip fracture among older women and men", Ann Intern Med, 152, pp.380~390 (2010)
- Khosla S, "Osteoporosis in men", Endocr Rev, 29, pp.441~464 (2008)
- Cummings SR, "Denosumab for prevention of fractures in postmenopausal women with osteoporosis", N Engl J Med, 361, pp.756~765 (2009)
- "Full prescribing information for PROLIA" (2019)[URL]
- Tsourdi E, "Fracture risk and management of discontinuation of denosumab therapy : a systematic review and position statement by ECTS", J Clin Endocrinol Metab, 106, pp.264~281 (2021)
- Silva BC, "Trabecular bone score : a noninvasive analytical method based upon the DXA image", J Bone Miner Res, 29, pp.518~530 (2014)
- Ramalho J, "The trabecular bone score : relationships with trabecular and cortical microarchitecture measured by HR-pQCT and histomorphometry in patients with chronic kidney disease", Bone, 116, pp.215~220 (2018)
- 공성혜, "Application of the Trabecular Bone Score in Clinical Practice", 대한골대사학회지, 28(2), pp.101~113 (2021), 대한골대사학회
- Silva BC, "Fracture risk prediction by non-BMD DXA measures : the 2015 ISCD official positions part 2. Trabecular bone score", J Clin Densitom, 18, pp.309~330 (2015)
- Krohn K, "Dual-energy X-ray absorptiometry monitoring with trabecular bone score : 2019 ISCD official position", J Clin Densitom, 22, pp.501~505 (2019)
- Orwoll E, "A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density", J Clin Endocrinol Metab, 97, pp.3161~3169 (2012)
- Smith MR, "Denosumab in men receiving androgen-deprivation therapy for prostate cancer", N Engl J Med, 361, pp.745~755 (2009)
- Makras P, "Denosumab versus zoledronate for the treatment of low bone mineral density in male HIV-infected patients", Bone Rep, 15, pp.101128~ (2021)
- Khosla S, "Effects of sex and age on bone microstructure at the ultradistal radius : a population-based noninvasive in vivo assessment", J Bone Miner Res, 21, pp.124~131 (2006)
- Aaron JE, "The microanatomy of trabecular bone loss in normal aging men and women", Clin Orthop Relat Res, 215, pp.260~271 (1987)
- McClung MR, "Denosumab in postmenopausal women with low bone mineral density", N Engl J Med, 354, pp.821~831 (2006)
- Kendler DL, "Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy", J Bone Miner Res, 25, pp.72~81 (2010)
- Miller PD, "Denosumab or zoledronic acid in postmenopausal women with osteoporosis previously treated with oral bisphosphonates", J Clin Endocrinol Metab, 101, pp.3163~3170 (2016)
- Dalle Carbonare L, "Bone microarchitecture as an important determinant of bone strength", J Endocrinol Invest, 27, pp.99~105 (2004)
- McClung MR, "Effect of denosumab on trabecular bone score in postmenopausal women with osteoporosis", Osteoporos Int, 28, pp.2967~2973 (2017)
- 정채호, "Effect of Romosozumab on Trabecular Bone Score Compared to Anti-Resorptive Agents in Postmenopausal Women with Osteoporosis", 대한골대사학회지, 28(4), pp.317~323 (2021), 대한골대사학회
- Seeman E, "Antiresorptive and anabolic agents in the prevention and reversal of bone fragility", Nat Rev Rheumatol, 15, pp.225~236 (2019)
- Tsai JN, "Effects of two years of teriparatide, denosumab, or both on bone microarchitecture and strength(DATA-HRpQCT study)", J Clin Endocrinol Metab, 101, pp.2023~2030 (2016)
- Morley J, "Persistence and compliance with osteoporosis therapies among postmenopausal women in the UK Clinical Practice Research Datalink", Osteoporos Int, 31, pp.533~545 (2020)
- Durden E, "Twoyear persistence and compliance with osteoporosis therapies among postmenopausal women in a commercially insured population in the United States", Arch Osteoporos, 12, pp.22~ (2017)
- Cheng LI, "Persistance and compliance with osteroporosis therapies among women in a commercially insured population in the United States", J Manag Care Spec Pharm, 21, pp.824~833 (2015)
- Silverman SL, "Persistence at 12 months with denosumab in postmenopausal women with osteoporosis : interim results from a prospective observational study", Osteoporos Int, 26, pp.361~372 (2015)
- Landfeldt E, "Adherence to treatment of primary osteoporosis and its association to fractures : the Swedish Adherence Register Analysis(SARA)", Osteoporos Int, 23, pp.433~443 (2012)
- Devine J, "A retrospective analysis of extended-interval dosing and the impact on bisphosphonate compliance in the US Military Health System", Osteoporos Int, 23, pp.1415~1424 (2012)
- Chandran M, "Adherence to dosing schedule of denosumab therapy for osteoporosis during COVID-19 lockdown : an electronic medical record and pharmacy claims database study from Asia", Osteoporos Int, 33, pp.251~261 (2022)