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

Chiba, Ko; Okazaki, Narihiro; Kurogi, Ayako; Watanabe, Tsuyoshi; Mori, Ai; Suzuki, Nobuhiko; Adachi, Koichi; Era, Makoto; Yokota, Kazuaki; Inoue, Takuma; Yabe, Yoshihiro; Furukawa, Keizo; Kondo, Choko; Tsuda, Keiichi; Ota, Shingo; Isobe, Yusaku; Miyazaki, Satsuki; Morimoto, Shimpei; Sato, Shuntaro; Nakashima, Sawako; Tashiro, Shigeki; Yonekura, Akihiko; Tomita, Masato; Osaki, Makoto

Affiliations

¹Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan

²Watanabe Orthopedic Clinic, Nagasaki University Hospital, Japan

³Nagasaki Yurino Hospital, Nagasaki University Hospital, Japan

⁴Juko Memorial Nagasaki Hospital, Nagasaki University Hospital, Japan

⁵Furukawa Orthopedic Clinic, Nagasaki University Hospital, Japan

⁶Kondo Orthopedic Clinic, Nagasaki University Hospital, Japan

⁷Clinical Research Center, Nagasaki University Hospital, Japan

Abstract and keywords

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.

Keywords: Teriparatide; Weekly teriparatide; High-dose teriparatide; High-resolution peripheral quantitative computed tomography (HR-pQCT); Bone microarchitecture

Links

DOI: 10.1016/j.bone.2022.116416

PubMed: 35398293

WoS: 000791661600005

History

Received: 2021-12-16

Revised: 2022-04-1

Accepted: 2022-04-4

Online: 2022-04-6

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Cited By (1)

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2023	Agarwal S, Shiau S, Kamanda-Kosseh M, Bucovsky M, Kil N, Lappe JM, Stubby J, Recker RR, Guo XE, Shane E, Cohen A. Teriparatide followed by denosumab in premenopausal idiopathic osteoporosis: bone microstructure and strength by HR-pQCT. J Bone Miner Res. January 2023;38(1):35-47.