Assessing the effect of baseline status of serum bone turnover markers and vitamin D levels on efficacy of teriparatide [amount hidden] administered subcutaneously in Japanese patients with osteoporosis

What Was Tested

Researchers studied Teriparatide in the context of osteoporosis and bone density in this randomized controlled trial publication.

The BTMs included were type I procollagen N-terminal pro-peptide (P1NP) and type I collagen cross-linked C-telopeptide (CTX).

Changes in BMD were analyzed by subgroups: (1) tertile subgroups of BTM; (2) BTM determined by the upper limit of normal; and (3) level of vitamin D.

Who Took Part

PubMed tags the participants as women only.

Subjects were randomized 2:1 to teriparatide versus placebo (teriparatide n = 137, placebo-teriparatide n = 70).

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label, placebo-controlled and multicenter study.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

Being open-label, the Teriparatide study did not mask who received what.

A placebo (an inactive look-alike) gave the Teriparatide group a baseline to be compared against.

What Was Measured

Changes in BMD were analyzed by subgroups: (1) tertile subgroups of BTM; (2) BTM determined by the upper limit of normal; and (3) level of vitamin D.

Topics PubMed links to this paper include Asian People, Biomarkers, Bone Density Conservation Agents, Bone Remodeling, Japan, Osteoporosis and Teriparatide.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Teriparatide in people with osteoporosis and bone density.

The publication is from 2013 (Journal of bone and mineral metabolism), a journal based in Japan.

More context: the Teriparatide compound page, Osteoporosis and bone density research.