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Safety, tolerability, pharmacokinetics, and pharmacodynamics of recombinant human parathyroid hormone (1-34) in healthy Chinese subjects
Plain-language guide to PMID 24793535 (2014): open-label randomized controlled trial study of Teriparatide and Parathyroid Hormone (PTH 1-84) in 1, subjects.
Key Facts
- PMID
- 24793535
- Journal
- Clinical therapeutics
- Year
- 2014
- Study type
- Randomized Controlled Trial
- Authors
- Liu Y et al. (8 authors)
- DOI
- 10.1016/j.clinthera.2014.03.015
What This Study Did, in Plain Language
What Was Tested
The paper reports a study of Teriparatide and Parathyroid Hormone (PTH 1-84), published as a randomized controlled trial.
The recombinant human parathyroid hormone (1-34) (rhPTH[1-34]) teriparatide is the first anabolic agent approved by the US Food and Drug Administration for the treatment of osteoporosis in men and women.
This study was conducted to provide support for marketing authorization of an agent biosimilar to teriparatide in China.
Who Took Part
The study group was 1, subjects.
By PubMed's age tags, the people studied were young adults, adults and middle-aged adults, both men and women.
How the Study Was Run
The design is described as randomized and open-label.
Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.
Being open-label, the Teriparatide study did not mask who received what.
What Was Measured
PubMed files the paper under topics including Asian People, Bone Density Conservation Agents, Healthy Volunteers, Teriparatide and United States.
Author keywords: recombinant human parathyroid hormone (1–34), safety profile and tolerability.
What This Means in Plain Language
The paper is a randomized and open-label study of Teriparatide and Parathyroid Hormone (PTH 1-84) in 1, subjects.
With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.
Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2014 (Clinical therapeutics), a journal based in United States.
More context: the Teriparatide compound page and the Parathyroid Hormone (PTH 1-84) compound page, all human trials.
Our Notes on the Compounds
Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.
Parathyroid Hormone (PTH 1-84): The 84-amino-acid hormone that raises blood calcium; full-length PTH (Natpara) has been used in hypoparathyroidism. Teriparatide is its 1-34 fragment.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.