Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1–31)NH2] in postmenopausal women with osteoporosis

Henriksen, Kim; Andersen, J.R.; Riis, B.J.; Mehta, Natasha; Tavakkol, Roxanne; Alexandersen, Peter; Byrjalsen, I.; Valter, Ivo; Nedergaard, Bettina; Teglbjærg, Christence Stubbe; Stern, William; Sturmer, A.; Mitta, S.; Nino, Antonio; Fitzpatrick, L.A.; Christiansen, C.; Karsdal, Morten A.

doi:10.1016/j.bone.2012.11.045

Cited by 53 publications

(35 citation statements)

References 20 publications

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“…In the oral PTH study arm, the bone formation marker OC was increased by 32%, 21% and 23% at Weeks 4, 12 and 24, respectively. There was no significant increase in the level of the bone resorption marker CTX [155].…”

Section: Peptides From the Parathyroid Hormone Familymentioning

confidence: 69%

Efficacy and safety of currently marketed anti-osteoporosis medications

Reginster

Neuprez

Dardenne

et al. 2014

Best Practice & Research Clinical Endocrinology & Metab

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Section: Peptides From the Parathyroid Hormone Familymentioning

confidence: 69%

Efficacy and safety of currently marketed anti-osteoporosis medications

Reginster

Neuprez

Dardenne

et al. 2014

Best Practice & Research Clinical Endocrinology & Metab

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“…34 A study of a formulation containing [rhPTH(1-31)NH 2 ] with an acylcarnitine in postmenopausal women with osteoporosis had adverse events such as abdominal pain, but they were attributed to PTH rather than the acylcarnitine. 35 …”

Section: Acyl Carnitinesmentioning

confidence: 99%

Safety concerns over the use of intestinal permeation enhancers: A mini-review

2016

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Intestinal permeation enhancers (PEs) are key components in »12 oral peptide formulations in clinical trials for a range of molecules, primarily insulin and glucagon-like-peptide 1 (GLP-1) analogs. The main PEs comprise medium chain fatty acid-based systems (sodium caprate, sodium caprylate, and N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC)), bile salts, acyl carnitines, and EDTA. Their mechanism of action is complex with subtle differences between the different molecules. With the exception of SNAC and EDTA, most PEs fluidize the plasma membrane causing plasma membrane perturbation, as well as enzymatic and intracellular mediator changes that lead to alteration of intestinal epithelial tight junction protein expression. The question arises as to whether PEs can cause irreversible epithelial damage and tight junction openings sufficient to permit co-absorption of payloads with bystander pathogens, lipopolysaccharides and its fragment, or exo-and endotoxins that may be associated with sepsis, inflammation and autoimmune conditions. Most PEs seem to cause membrane perturbation to varying extents that is rapidly reversible, and overall evidence of pathogen co-absorption is generally lacking. It is unknown however, whether the intestinal epithelial damage-repair cycle is sustained during repeat-dosing regimens for chronic therapy.

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“…A Phase II trial originally sponsored by Unigene (NCT01321723) included 97 women in a postmenopausal period and diagnosed with osteoporosis. Significant increases in lumbar spine bone mineral density was observed for oral rhPTH(1-31)NH2 administered once daily after 6 months compared to baseline values and PK and safety endpoints were also achieved [178,179]. A curiosity is that this peptide is not the same as the approved injected rhPTH (1-33) (teriparatide) and would be classified as an NCE.…”

Section: Phase IIImentioning

confidence: 99%

Current status of selected oral peptide technologies in advanced preclinical development and in clinical trials

Aguirre

Teijeiro‐Osorio

Rosa

et al. 2016

Advanced Drug Delivery Reviews

261

151

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Publication informationAdvanced Drug Delivery Reviews, 106 (Part B):Publisher Elsevier Item record/more information http://hdl.handle.net/10197/7801 Publisher's statementThis is the author's version of a work that was accepted for publication in Advanced Drug Delivery Reviews. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Advanced Drug Delivery Reviews (106, Part B, (2016)

show abstract

Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1–31)NH2] in postmenopausal women with osteoporosis

Cited by 53 publications

References 20 publications

Efficacy and safety of currently marketed anti-osteoporosis medications

Efficacy and safety of currently marketed anti-osteoporosis medications

Safety concerns over the use of intestinal permeation enhancers: A mini-review

Current status of selected oral peptide technologies in advanced preclinical development and in clinical trials

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