Two-Year Outcomes of Daily and Twice-Weekly Teriparatide Treatment in Postmenopausal Women with Severe Osteoporosis: A Randomized Non-Blinded Prospective Study
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Background: The long-term effects of daily teriparatide (D-TPTD) and twice-weekly TPTD (W-TPTD) injections are compared among postmenopausal women with severe osteoporosis. Methods: A total of 102 patients were enrolled and randomly allocated into two groups for the administration of either D-TPTD or W-TPTD. Treatment efficacy was measured as the percentage change in bone mineral density (ΔBMD) from baseline in the lumbar spine, total hip, and femoral neck. The findings were compared between the two groups. Results: At 24 months after treatment, the persistence rates and medication possession ratios in the D-TPTD and W-TPTD groups were 68.6% and 56.9%, and 87.8% and 92.0%, respectively. The ΔBMD in the lumbar spine, total hip, and femoral neck were 15.6%±10.2%, 5.3%± 6.3%, and 5.5%±6.2%, respectively, in the D-TPTD group; and 9.5%±7.9%, 2.3%±6.2%, and 3.1%±7.4%, respectively, in the W-TPTD group following 24 months of treatment. The ΔBMD of the lumbar spine (P=0.008) at 24 months and total hip (P=0.024) at 18 months differed significantly between the two groups. Conclusions: D-TPTD administration resulted in a significantly higher BMD in the lumbar spine and total hip, supporting this therapeutic regimen for postmenopausal women with severe osteoporosis.
Abstract
Background: The long-term effects of daily teriparatide (D-TPTD) and twice-weekly TPTD (W-TPTD) injections are compared among postmenopausal women with severe osteoporosis. Methods: A total of 102 patients were enrolled and randomly allocated into two groups for the administration of either D-TPTD or W-TPTD. Treatment efficacy was measured as the percentage change in bone mineral density (ΔBMD) from baseline in the lumbar spine, total hip, and femoral neck. The findings were compared between the two groups. Results: At 24 months after treatment, the persistence rates and medication possession ratios in the D-TPTD and W-TPTD groups were 68.6% and 56.9%, and 87.8% and 92.0%, respectively. The ΔBMD in the lumbar spine, total hip, and femoral neck were 15.6%±10.2%, 5.3%± 6.3%, and 5.5%±6.2%, respectively, in the D-TPTD group; and 9.5%±7.9%, 2.3%±6.2%, and 3.1%±7.4%, respectively, in the W-TPTD group following 24 months of treatment. The ΔBMD of the lumbar spine (P=0.008) at 24 months and total hip (P=0.024) at 18 months differed significantly between the two groups. Conclusions: D-TPTD administration resulted in a significantly higher BMD in the lumbar spine and total hip, supporting this therapeutic regimen for postmenopausal women with severe osteoporosis.
참고문헌 (27)
- Colón-Emeric CS, "Osteoporotic fractures in older adults", Best Pract Res Clin Rheumatol, 20, pp.695~706 (2006)[DOI]
- Nishimura A, "Osteoporosis, vertebral fractures and mortality in a Japanese rural community", Mod Rheumatol, 24, pp.840~843 (2014)[DOI]
- Obermayer-Pietsch BM, "Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment", J Bone Miner Res, 23, pp.1591~1600 (2008)[DOI]
- Body JJ, "Efficacy of teriparatide compared with risedronate on FRAX(®)-defined major osteoporotic fractures : results of the VERO clinical trial", Osteoporos Int, 31, pp.1935~1942 (2020)[DOI]
- Soen S, "Real-world effectiveness of daily teriparatide in Japanese patients with osteoporosis at high risk for fracture : final results from the 24-month Japan Fracture Observational Study(JFOS)", Curr Med Res Opin, 33, pp.2049~2056 (2017)[DOI]
- Sugimoto T, "Study of twice-weekly injections of teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients : the TWICE study", Osteoporos Int, 30, pp.2321~2331 (2019)[DOI]
- Tsuchie H, "Comparison of the continuation rate of twice-weekly and weekly teriparatide administration in a rural area", Tohoku J Exp Med, 260, pp.119~126 (2023)[DOI]
- Nakamura T, "Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis : two-year results from a randomized placebo-controlled double-blind study(ZOledroNate treatment in Efficacy to osteoporosis; ZONE study)", Osteoporos Int, 28, pp.389~398 (2017)[DOI]
- Chiba K, "Randomized controlled trial of daily teriparatide, weekly high-dose teriparatide, or bisphosphonate in patients with postmenopausal osteoporosis : the TERABIT study", Bone, 160, pp.116416~ (2022)[DOI]
- Cranney A, "Meta-analyses of therapies for postmenopausal osteoporosis. II. Meta-analysis of alendronate for the treatment of postmenopausal women", Endocr Rev, 23, pp.508~516 (2002)[DOI]
- Cranney A, "Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis", Endocr Rev, 23, pp.517~523 (2002)[DOI]
- Black DM, "Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis", N Engl J Med, 356, pp.1809~1822 (2007)[DOI]
- Cranney A, "Meta-analyses of therapies for postmenopausal osteoporosis. IV. Meta-analysis of raloxifene for the prevention and treatment of postmenopausal osteoporosis", Endocr Rev, 23, pp.524~528 (2002)[DOI]
- Cummings SR, "Denosumab for prevention of fractures in postmenopausal women with osteoporosis", N Engl J Med, 361, pp.756~765 (2009)[DOI]
- Neer RM, "Effect of parathyroid hormone(1-34)on fractures and bone mineral density in postmenopausal women with osteoporosis", N Engl J Med, 344, pp.1434~1441 (2001)[DOI]
- Once-Weekly Efficacy Research(TOWER)trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk, "J Clin Endocrinol Metab", 2012, 3097~3106, 10.1210[DOI]
- Yang D, "Contributions of parathyroid hormone(PTH)", PTH-related peptide receptor signaling pathways to the anabolic effect of PTH on bone, 2007, pp.40, 1453~1461
- Yamamoto T, "Frequency of teriparatide administration affects the histological pattern of bone formation in young adult male mice", Endocrinology, 157, pp.2604~2620 (2016)[DOI]
- Tanaka S, "New simulation model for bone formation markers in osteoporosis patients treated with once-weekly teriparatide", Bone Res, 2, pp.14043~ (2014)[DOI]
- Prevrhal S, "Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment", Curr Med Res Opin, 25, pp.921~928 (2009)[DOI]
- Langdahl BL, "Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide : 18-month data from the European Forsteo Observational Study(EFOS)", Calcif Tissue Int, 85, pp.484~493 (2009)[DOI]
- Bouxsein ML, "Change in bone density and reduction in fracture risk : a meta-regression of published trials", J Bone Miner Res, 34, pp.632~642 (2019)[DOI]
- Simpson EL, "Clinical effectiveness of denosumab, raloxifene, romosozumab, and teriparatide for the prevention of osteoporotic fragility fractures : a systematic review and network meta-analysis", Bone, 130, pp.115081~ (2020)[DOI]
- Kawai M, "Emerging therapeutic opportunities for skeletal restoration", Nat Rev Drug Discov, 10, pp.141~156 (2011)[DOI]
- Lim SY, "Profile of romosozumab and its potential in the management of osteoporosis", Drug Des Devel Ther, 11, pp.1221~1231 (2017)[DOI]
- Cosman F, "Romosozumab treatment in postmenopausal women with osteoporosis", N Engl J Med, 375, pp.1532~1543 (2016)[DOI]
- Langdahl BL, "Romosozumab(sclerostin monoclonal antibody)versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy : a randomised, open-label, phase 3 trial", Lancet, 390, pp.1585~1594 (2017)[DOI]