Novel Parathyroid Hormone-Based Bone Graft, KUR-113, in Treatment of Acute Open Tibial Shaft Fracture: A Phase-2 Randomized Controlled Trial

What Was Tested

This randomized controlled trial paper looks at Parathyroid Hormone (PTH 1-84).

Parathyroid hormone (PTH) plays a key role in bone metabolism.

See Instructions for Authors for a complete description of levels of evidence.

Who Took Part

The study group was 200 subjects.

Subjects were followed for up to 12 months after treatment.

The primary end point was the proportion of subjects with fracture healing at 6 months.

How the Study Was Run

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

The subjects were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

Everyone knew when Parathyroid Hormone (PTH 1-84) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The methods mention a period of 12 months.

KUR-113 was administered at the fracture site after internal fracture fixation and before wound closure.

The primary outcome measure was fracture healing at 6 months assessed by the study investigator using radiographic and clinical measures.

What Was Measured

See Instructions for Authors for a complete description of levels of evidence.

The subject headings attached to it are Bone Transplantation, Fracture Healing, Fractures, Open, Parathyroid Hormone and Tibial Fractures.

What This Means in Plain Language

The paper is a randomized and open-label study of Parathyroid Hormone (PTH 1-84) in 200 subjects over 12 months.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2022 (The Journal of bone and joint surgery. American volume), a journal based in United States.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.