Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta

What Was Tested

This clinical study looks at Teriparatide.

Questionnaires will be completed to assess pain and other aspects of health-related quality of life (HRQoL).

Why It Was Studied

The study received ethical approval in December 2016.

Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal.

Who Took Part

The age groups tagged for this paper are teenagers and adults.

Individuals aged ≥18 years with a clinical diagnosis of OI are eligible to take part.

At baseline, participants will undergo a spine X-ray, and have bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) at the spine and hip.

How the Study Was Run

The researchers set it up as a randomized study.

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

Information on previous fractures and previous bone targeted treatments will be collected.

Participants will be followed up annually, have a repeat DXA at 2 years and at the end of study.

Spine X-rays will be repeated at the end of study.

The duration of follow-up will range between 2 and 8 years.

The primary endpoint will be new clinical fractures confirmed by X-ray or other imaging.

What Was Measured

Secondary endpoints will include participant reported fractures, BMD and changes in pain and HRQoL.

PubMed files the paper under topics including Zoledronic Acid, Teriparatide, Osteogenesis Imperfecta, Bone Density Conservation Agents, Quality of Life, Fractures, Bone and Bone Density.

Author keywords: calcium & bone, internal medicine, randomized controlled trial and rheumatology.

What This Means in Plain Language

The paper is a randomized study of Teriparatide.

The publication is from 2023 (BMJ open), a journal based in England.

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