A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis

What Was Tested

This randomized controlled trial paper looks at Teriparatide.

RGB-10 is the first biosimilar teriparatide authorized in the European Union.

Who Took Part

The study group was 250 patients.

The age groups tagged for this paper are middle-aged adults and older adults, both men and women.

How the Study Was Run

In design terms this was a randomized, single-blind, multicenter and parallel-group study.

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

Only one side, usually the patients, was kept unaware of whether Teriparatide was given.

Running at several centres spread the Teriparatide study over different clinics and patient groups.

The Teriparatide group and the comparison group ran side by side rather than switching.

Safety outcomes and immunogenicity were also assessed.

What Was Measured

Topics PubMed links to this paper include Bone Density, Bone Density Conservation Agents, Lumbar Vertebrae, Osteoporosis, Osteoporotic Fractures, Teriparatide and Therapeutic Equivalency.

Author keywords: BMD, Biosimilar, Clinical trial and RGB-10.

What This Means in Plain Language

The paper is a randomized, single-blind and multicenter study of Teriparatide in 250 patients.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2019 (Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA), a journal based in England.

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