Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures

What Was Tested

This registered phase 3 trial tested Teriparatide.

Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often occur without warning, are highly debilitating, and are slow to heal.

It had two arms (groups): one (active comparator) and Placebo (placebo comparator).

Placebo injection pen identical to active drug injection pen.

The registry classes the interventions as biological and other.

Who Took Part

Enrollment: 34 actual participants took part.

It was open to people of any sex aged from 30 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height;. From distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: pregnant or nursing mothers, or women who are planning on pregnancy within 1 year of completing teriparatide therapy,; hypersensitivity to teriparatide,; severe renal impairment,.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-07 with completion listed for 2021-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the modified The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)of the affected limb (the femur that has the incomplete AFF) (time frame: baseline to 12 months). The proportion of patients requiring surgical intervention (time frame: baseline to 12 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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