Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation

What Was Tested

The paper reports a study of Teriparatide, published as a randomized controlled trial.

Serum procollagen type I N-terminal propeptide (PINP), a representative marker of bone anabolic action, is strongly related to bone mineral density during teriparatide therapy.

This post hoc study analyzed data from a Phase III study (ClinicalTrials.gov identifier NCT00433160) to determine if there was an association between serum PINP elevation and serum calcium concentration or calcium metabolism-related disorders.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label and placebo-controlled study.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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.

Some participants received a placebo instead of Teriparatide, giving a reference point.

The methods mention a period of 12 months.

What Was Measured

PubMed files the paper under topics including Biomarkers, Body Mass Index, Bone Density, Bone Density Conservation Agents, Calcium, Japan and Osteoporosis.

Author keywords: bone metabolism markers, hypercalcemia, procollagen type I N-terminal propeptide and teriparatide.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Teriparatide over 12 months.

Results are reported in around 9 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (Clinical interventions in aging), a journal based in New Zealand.

More context: the Teriparatide compound page, all human trials.