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Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, 6-month, phase 2 study
Plain-language guide to PMID 38578978 (2024): double-blind randomized controlled trial study of Teriparatide in 161 patients.
Key Facts
- PMID
- 38578978
- Journal
- Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
- Year
- 2024
- Study type
- Randomized Controlled Trial
- Authors
- Tripto-Shkolnik L et al. (12 authors)
- DOI
- 10.1093/jbmr/zjae057
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Teriparatide.
The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
Why It Was Studied
Anabolic treatment is indicated for high and very-high risk patients with osteoporosis, but acceptance is limited because current anabolic medications require subcutaneous injections.
Who Took Part
According to the abstract, 161 patients were involved.
By PubMed's age tags, the people studied were middle-aged adults and older adults, women only.
How the Study Was Run
The researchers set it up as a randomized, double-blind and placebo-controlled study.
Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.
As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.
Some patients received a placebo instead of Teriparatide, giving a reference point.
Biochemical markers were assessed at 1, 2, 3, and 6 mo and BMD of LS, TH, and FN was measured at 6 mo.
What Was Measured
Topics PubMed links to this paper include Bone Density, Biomarkers, Tablets, Postmenopause, Osteoporosis, Postmenopausal, Parathyroid Hormone and Teriparatide.
Author keywords: EBP05/EB613, Entera Bio, oral PTH, oral hPTH(1-34), oral teriparatide and osteoanabolics.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study of Teriparatide in 161 patients.
The publication is from 2024 (Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research), a journal based in England.
More context: the Teriparatide compound page, all human trials.
Our Notes on the Compound
Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.
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.