Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

What Was Tested

Researchers studied Teriparatide in this randomized controlled trial publication.

Teriparatide (Forteo(®)/ Forsteo(®), recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk.

Who Took Part

The abstract describes 1220 patients taking part.

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, both men and women.

The researchers initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication.

The trials were conducted concurrently with a planned enrollment of 1220 patients per trial.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Some patients received a placebo instead of Teriparatide, giving a reference point.

However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols.

Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced).

An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs.

A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide).

What Was Measured

Topics PubMed links to this paper include Biomechanical Phenomena, Bone Density Conservation Agents, Bone Screws, Combined Modality Therapy, Femoral Neck Fractures, Femur Neck and Fracture Fixation, Internal.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Teriparatide in 1220 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2016 (Clinical orthopaedics and related research), a journal based in United States.

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