The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

What Was Tested

The trial (phase 3) is built around Teriparatide.

Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.

It had two arms (groups): Teriparatide (experimental) and Placebo (placebo comparator).

Placebo subcutaneous once daily for 12 weeks.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively.

Each participant will be in the study for 6 months in total.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: Male and female patient, age ≥ 50 years at the time of screening. Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3). Treated by proximal femoral nail antirotation (PFNA).

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: known hypersentivity to teriparatide or any form of pth or analogue; metabolic bone disease other than primary osteoporosis (including hyper parathyroidism and paget's disease of bone); abnormally elevated serum intact parathyroid hormone at screening (serum pth \> 70 pg/ml).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-05-17 with completion listed for 2022-06-01.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to healing assessed by radiographic evidence (time frame: from randomization, assessed up to 24 months).

It also tracked 3 secondary outcomes, for example Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes, Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes and Clinical evidence of healing assessed by walking ability as one of functional outcomes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 50 people.

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.