Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial

What Was Tested

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

National Institutes of Health and the Dart Foundation.

Who Took Part

By PubMed's age tags, the people studied were older adults, women only.

Treatment was given open label, but outcome assessors were masked.

How the Study Was Run

In design terms this was a randomized and open-label study.

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

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.

DATA-HD was an open-label, randomised, controlled phase 4 trial done at Massachusetts General Hospital.

Areal BMD (aBMD) was measured at 0, 3, 9, and 15 months.

The primary endpoint was percentage change from baseline in spine areal BMD (aBMD) at 15 months.

Women who completed at least one study visit after baseline were included in the modified intention-to-treat analysis.

Safety was assessed in all randomly assigned participants.

What Was Measured

The subject headings attached to it are Bone Density, Bone Density Conservation Agents, Bone Resorption, Denosumab, Osteoporosis, Postmenopausal and Teriparatide.

What This Means in Plain Language

The paper is a randomized and open-label study of Teriparatide.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Teriparatide compound page.