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

被引:24
作者
Chiba, Ko [1 ]
Okazaki, Narihiro [1 ]
Kurogi, Ayako [1 ]
Watanabe, Tsuyoshi [2 ]
Mori, Ai [3 ]
Suzuki, Nobuhiko [3 ]
Adachi, Koichi [3 ]
Era, Makoto [1 ]
Yokota, Kazuaki [1 ]
Inoue, Takuma [4 ]
Yabe, Yoshihiro [4 ]
Furukawa, Keizo [5 ]
Kondo, Choko [6 ]
Tsuda, Keiichi [1 ]
Ota, Shingo [1 ]
Isobe, Yusaku [1 ]
Miyazaki, Satsuki [1 ]
Morimoto, Shimpei [7 ]
Sato, Shuntaro [7 ]
Nakashima, Sawako [7 ]
Tashiro, Shigeki [7 ]
Yonekura, Akihiko [1 ]
Tomita, Masato [1 ]
Osaki, Makoto [1 ]
机构
[1] Nagasaki Univ, Dept Orthoped Surg, Nagasaki Univ Hosp, Grad Sch Biomed Sci, Nagasaki, Japan
[2] Nagasaki Univ Hosp, Watanabe Orthoped Clin, Nagasaki, Japan
[3] Nagasaki Univ Hosp, Nagasaki Yurino Hosp, Nagasaki, Japan
[4] Nagasaki Univ Hosp, Juko Mem Nagasaki Hosp, Nagasaki, Japan
[5] Nagasaki Univ Hosp, Furukawa Orthoped Clin, Nagasaki, Japan
[6] Nagasaki Univ Hosp, Kondo Orthoped Clin, Nagasaki, Japan
[7] Nagasaki Univ Hosp, Clin Res Ctr, Nagasaki, Japan
关键词
Teriparatide; Weekly teriparatide; High-dose teriparatide; High-resolution peripheral quantitative computed tomography (HR-pQCT); Bone microarchitecture; CORTICAL BONE MICROARCHITECTURE; ESTIMATED STRENGTH; HIGH-RISK; PTH; 1-34; FRACTURE; EFFICIENCY; DENOSUMAB; THERAPY; DENSITY; WOMEN;
D O I
10.1016/j.bone.2022.116416
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Purpose: The effects of daily teriparatide (20 mu g) (D-PTH), weekly high-dose teriparatide (56.5 mu g) (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.
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页数:11
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