Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis

What Was Tested

Researchers studied Teriparatide and Parathyroid Hormone (PTH 1-84) in this randomized controlled trial publication.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, women only.

Women diagnosed with postmenopausal osteoporosis as detected by lumbar spine DXA, with an exclusion of those with prior treatment with bone active agents.

How the Study Was Run

The design is described as randomized, double-blind, open-label and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The comparison arm used a placebo, so changes seen with Teriparatide could be set against what happens without it.

Orally formulated recombinant human PTH(1-31)NH(2) and placebo, or open-label subcutaneous teriparatide as a positive control.

What Was Measured

Topics PubMed links to this paper include Bone Density, Enzyme-Linked Immunosorbent Assay, Osteoporosis, Postmenopausal, Parathyroid Hormone, Peptide Fragments and Recombinant Proteins.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Teriparatide and Parathyroid Hormone (PTH 1-84).

Its findings take up roughly 10 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2013 (Bone), a journal based in United States.

More context: the Teriparatide compound page and the Parathyroid Hormone (PTH 1-84) compound page.