Fracture (FX) Improvement With Teriparatide: FiX-IT Study

What Was Tested

In this phase 4 trial, researchers set out to test Teriparatide.

Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.

It had two arms (groups): Immediate teriparatide (experimental) and Delayed teriparatide (experimental).

Open label teriparatide given immediately following surgical repair of fracture.

Open label teriparatide given six months following surgical repair of fracture.

The registry classes the interventions as drug.

More on the Plan

Up to 24 postmenopausal women with osteoporosis who have been on bisphosphonate therapy for one year or more at any point prior to fracture and have sustained an atypical subtrochanteric or diaphyseal fracture will be enrolled.

Subjects randomized to the two intervention arms will self-administer a daily SQ injection of the study medication for 12 months.

Who Took Part

13 actual participants took part.

It was open to women only.

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

Examples of who could join: With osteoporosis who have been on bisphosphonate therapy for one year or more (all bisphosphonates will be included such as alendronate, risdedronate, ibandronate, or zoledronic acid).

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: those who have had radiation therapy; paget's disease; treatment with teriparatide for two year in the past.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 participants stayed in one arm throughout.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2012-12 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Radiologic Evidence of Bone Healing (time frame: 6, 12 months of treatment). Radiologic Evidence of Healing (time frame: at 10 weeks for immediate teriparatide group).

It also tracked 4 secondary outcomes, for example Radiologic Healing and Difference in Biochemical Markers of Bone Turnover.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 13 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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