Teriparatide and stress fracture healing in young adults (RETURN - Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial

What Was Tested

The paper reports a study of Teriparatide, published as a clinical study.

The study aim is to investigate the effect of teriparatide on stress fracture healing in young, otherwise healthy adults undergoing military training.

Why It Was Studied

Stress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes.

Recovery from a lower body stress fracture typically requires several weeks of physical rehabilitation.

Who Took Part

The abstract describes 136 men taking part.

PubMed indexes the participants as young adults, both men and women.

In a two-arm, parallel, prospective, randomised controlled, intention-to-treat trial, Army recruits (n = 136 men and women, 18-40 years) with a magnetic resonance imaging (MRI) diagnosed lower body stress fracture (pelvic girdle, sacrum, coccyx, or lower limb) will be randomised to receive either usual Army standard care, or teriparatide and usual Army standard care.

How the Study Was Run

The design is described as randomized and parallel-group.

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

Groups ran in parallel: each of the men stayed in one arm throughout.

Secondary outcomes will be time to radiological healing, assessed by MRI at 8, 10, 12, 14, 16, 20 and 24 weeks, until healed; time to clinical healing, assessed using a clinical severity score of injury signs and symptoms; time to discharge from Army physical rehabilitation; pain, assessed by visual analogue scale; health-related quality of life, using the Short Form (36) Health Survey; and adverse events.

Exploratory outcomes will include blood and urine biochemistry; bone density and morphology assessed using dual-energy X-ray absorptiometry, peripheral quantitative computed tomography (pQCT), and high-resolution pQCT; physical activity measured using accelerometers; and long-term future fracture rate.

What Was Measured

PubMed files the paper under topics including Bone Density Conservation Agents, Fracture Healing, Fractures, Stress, Quality of Life, Randomized Controlled Trials as Topic and Teriparatide.

The authors tagged it with the keywords Intention-to-treat, Magnetic resonance imaging, Military, Musculoskeletal injury, Parathyroid hormone and Prospective randomised controlled trial.

What This Means in Plain Language

The paper is a randomized and parallel-group study of Teriparatide in 136 men.

The abstract goes on to report its results in about 1 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (Trials), a journal based in England.

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