PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial

What Was Tested

The trial (phase 2) is built around Teriparatide.

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

The registry classes the interventions as drug.

More on the Plan

Pelvic fractures are accompanied by severe pain, chronic immobility and loss of function and independence in the elderly.

Pelvic fractures consume substantial healthcare resources, and based on administrative claims data, they are one of the most costly osteoporosis related fractures.

Un-healed fractures, occurring in one-third of pelvic fracture patients at 3 months, can cause continued pain and impact mobility.

A positive finding of accelerated healing of pelvic fractures would also encourage study of TPTD for treatment of other osteoporotic fractures.

Who Took Part

The registry lists 35 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

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

The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: persons unable to complete the nrs and other surveys based on their mini-mental status score (≤18; consistent with moderate and severe cognitive impairment); previously (prior to fracture) non-ambulatory subjects; exclusion criteria related to contraindication or intolerance to tptd:.

How the Study Was Run

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

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

The Teriparatide group and the comparison group ran side by side rather than switching.

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, care provider, investigator and outcomes assessor.

It started in 2017-05-01 with completion listed for 2021-03-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Evidence of Cortical Bridging for Fracture Healing (time frame: 3 months).

It also tracked 4 secondary outcomes, for example Change in Pain by Numeric Rating Scale Between Baseline and Three Months, Functional Outcome Using a Battery That Includes Walking Speed, Repeated Chair Stands, and Balance at 3 Months, Physical Function at 12 Months Using a Battery That Includes Walking Speed, Repeated Chair Stands, and Balance and Pain at 12 Months Based on the Numeric Rating Scale.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 35 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.