Trial reportClinical pharmacology in drug development2020
Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice-Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single-Blind Randomized Study.
Trial report in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 9 citations in OpenAlex.
- A crossover comparison of patient satisfaction with two teriparatide regimens: primary results of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06).Journal of bone and mineral metabolism · 2024Trial
- Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019Trial
- Clinical outcomes of twice-weekly teriparatide acetate administration in osteoporosis.Archives of osteoporosis · 2025Article
- Personalized Approaches to Spine Surgery.International journal of spine surgery · 2024Article
- Medical optimization of osteoporosis for adult spinal deformity surgery: a state-of-the-art evidence-based review of current pharmacotherapy.Spine deformity · 2023Review
- Efficacy of once-weekly and twice-weekly injections of teriparatide by patient characteristics: A post hoc analysis of the TWICE study.Osteoporosis and sarcopenia · 2021Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Once-weekly injection of 56.5-μg teriparatide formulation is a potent therapeutic agent for osteoporosis treatment. However, this treatment has an issue of difficulty in continuing the treatment by its adverse side effects including nausea, vomiting, and headaches. To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections. Different dosing intervals of the twice-weekly 28.2-μg injections were also studied. A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study. The systemic exposure of teriparatide acetate in the twice-weekly 28.2-μg injection was half that of the once-weekly 56.5-μg injection. Changes in bone turnover markers in the twice-weekly 28.2-μg injection were comparable to those in the once-weekly 56.5-μg injection. Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection. Findings were similar in the twice-weekly 28.2-μg injections regardless of the dosing interval. Thus, the new dosing regimen using twice-weekly 28.2-μg injections maintained comparable efficacy to the once-weekly 56.5-μg injections; however, it improved the safety profile and contributed to better continuity of care with teriparatide.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.