Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial

What Was Tested

This randomized controlled trial paper looks at Teriparatide.

No clinical trials have compared osteoporosis drugs with incident fractures as the primary outcome.

Who Took Part

PubMed indexes the participants as middle-aged adults, older adults and people over 80, women only.

In this double-blind, double-dummy trial, the researchers enrolled post-menopausal women with at least two moderate or one severe vertebral fracture and a bone mineral density T score of less than or equal to -1·50.

How the Study Was Run

In design terms this was a randomized, double-blind 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.

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

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

The primary outcome was new radiographic vertebral fractures.

Secondary, gated outcomes included new and worsened radiographic vertebral fractures, clinical fractures (a composite of non-vertebral and symptomatic vertebral), and non-vertebral fractures.

This study is registered with ClinicalTrials.gov (NCT01709110) and EudraCT (2012-000123-41).

What Was Measured

No clinical trials have compared osteoporosis drugs with incident fractures as the primary outcome.

The subject headings attached to it are Americas, Bone Density, Bone Density Conservation Agents, Europe, Incidence, Osteoporosis, Postmenopausal and Osteoporotic Fractures.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Teriparatide.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2018 (Lancet (London, England)), a journal based in England.

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