Timing optimization of teriparatide dosing for postmenopausal osteoporosis: a randomized controlled trial

作者：Huan Wang, Liyuan Tao, Dongyang Liu, Xiaoyan Yan, Hai-Yan Li, Chun-Li Song · 发表于：Journal of Orthopaedic Surgery and Research · 年份：2025 · DOI：10.1186/s13018-025-06083-6 · 被引用次数：5 · 研究领域：Medicine

Accumulating evidence highlights the critical role of circadian rhythms in regulating bone turnover. Bone turnover markers, including parathyroid hormone, C-terminal telopeptide of type I collagen, and N-terminal propeptide of type I procollagen, all exhibit distinct diurnal variations. Teriparatide, a recombinant parathyroid hormone analog, demonstrates time-dependent efficacy influenced by these endogenous rhythms. However, the impact of administration timing on bone metabolism remains underexplored. This randomized, open-label, exploratory trial investigates the impact of teriparatide administration timing by comparing subcutaneous injection at 08:00 versus 20:00 on bone turnover markers in postmenopausal women with osteoporosis. Twenty-eight participants (aged 60–70 years, lumbar spine T-score ≤ -3.0) will be randomized in a 1:1 ratio to receive 20 µg/day of teriparatide via subcutaneous injection at either 08:00 or 20:00 for 12 weeks. All participants will receive standardized calcium (1000–1500 mg/day) and cholecalciferol (800–1200 IU/day) supplementation throughout the study period. The primary outcomes are the between-group differences in serum parathyroid hormone, C-terminal telopeptide of type I collagen, and N-terminal propeptide of type I procollagen profiles, which will be assessed at baseline, 4 weeks, and 12 weeks. Secondary outcomes will evaluate the safety profile during the trial. This trial is expected to provide crucial insights into optimizing teriparatid...