Randomized controlled trial of daily teriparatide, weekly high-dose teriparatide, or bisphosphonate in patients with postmenopausal osteoporosis: The TERABIT study.

Autor: Chiba K; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan. Electronic address: kohchiba@estate.ocn.ne.jp., Okazaki N; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Kurogi A; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Watanabe T; Watanabe Orthopedic Clinic, Nagasaki University Hospital, Japan., Mori A; Nagasaki Yurino Hospital, Nagasaki University Hospital, Japan., Suzuki N; Nagasaki Yurino Hospital, Nagasaki University Hospital, Japan., Adachi K; Nagasaki Yurino Hospital, Nagasaki University Hospital, Japan., Era M; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Yokota K; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Inoue T; Juko Memorial Nagasaki Hospital, Nagasaki University Hospital, Japan., Yabe Y; Juko Memorial Nagasaki Hospital, Nagasaki University Hospital, Japan., Furukawa K; Furukawa Orthopedic Clinic, Nagasaki University Hospital, Japan., Kondo C; Kondo Orthopedic Clinic, Nagasaki University Hospital, Japan., Tsuda K; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Ota S; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Isobe Y; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Miyazaki S; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Morimoto S; Clinical Research Center, Nagasaki University Hospital, Japan., Sato S; Clinical Research Center, Nagasaki University Hospital, Japan., Nakashima S; Clinical Research Center, Nagasaki University Hospital, Japan., Tashiro S; Clinical Research Center, Nagasaki University Hospital, Japan., Yonekura A; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Tomita M; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan., Osaki M; Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan.
Jazyk: angličtina
Zdroj: Bone [Bone] 2022 Jul; Vol. 160, pp. 116416. Date of Electronic Publication: 2022 Apr 06.
DOI: 10.1016/j.bone.2022.116416
Abstrakt: Purpose: The effects of daily teriparatide (20 μg) (D-PTH), weekly high-dose teriparatide (56.5 μg) (W-PTH), or bisphosphonates (BPs) on areal bone mineral density (aBMD), bone turnover markers (BTMs), volumetric BMD (vBMD), microarchitecture, and estimated strength were investigated in postmenopausal osteoporosis patients.
Methods: The study participants were 131 women with a history of fragility fractures. They were randomized to receive D-PTH, W-PTH, or BPs (alendronate or risedronate) for 18 months. Dual-energy X-ray absorptiometry (DXA), BTMs, and high-resolution peripheral quantitative CT (HR-pQCT) parameters were evaluated at baseline and after 6 and 18 months of treatment. The primary endpoint was the change (%) in cortical thickness (Ct.Th) after 18 months' treatment compared with baseline.
Results: DXA showed that D-PTH, W-PTH, and BPs increased lumbar spine aBMD (+12.0%, +8.5%, and +6.8%) and total hip aBMD (+3.0%, +2.1%, and +3.0%), but D-PTH and W-PTH decreased 1/3 radius aBMD (-4.1%, -3.0%, -1.4%) after 18 months. On HR-pQCT, D-PTH increased trabecular vBMD (Tb.vBMD) at the distal radius and tibia after 18 months (+6.4%, +3.7%) compared with the BPs group, decreased cortical volumetric tissue mineral density (Ct.vTMD) (-1.8%, -0.9%) compared with the other groups, increased Ct.Th (+1.3%, +3.9%), and increased failure load (FL) (+4.7%, +4.4%). W-PTH increased Tb.vBMD (+5.3%, +1.9%), maintained Ct.vTMD (-0.7%, +0.2%) compared with D-PTH, increased Ct.Th (+0.6%, +3.6%), and increased FL (+4.9%, +4.5%). The BPs increased Tb.vBMD only in the radius (+2.0%, +0.2%), maintained Ct.vTMD (-0.6%, +0.3%), increased Ct.Th (+0.5%, +3.4%), and increased FL (+3.9%, +2.8%).
Conclusions: D-PTH and W-PTH comparably increased Ct.Th, the primary endpoint. D-PTH had a strong effect on trabecular bone. Although D-PTH decreased Ct.vTMD, it increased Ct.Th and total bone strength. W-PTH had a moderate effect on trabecular bone, maintained Ct.vTMD, and increased Ct.Th and total bone strength to the same extent as D-PTH.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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