Use of Teriparatide to Accelerate Fracture Healing

What Was Tested

This registered not phased trial tested Teriparatide.

The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

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

30 participants will receive teriparatide (Forteo) injection pens.

30 participants will receive placebo injection pens.

The registry classes the interventions as drug.

More on the Plan

Teriparatide is a man-made form of a naturally occurring hormone called parathyroid.

The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.

This study will last 16 weeks.

Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

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

Examples of who could join: Females must be menopausal (no menses within the last 12 months). Maximum of 2 weeks post fracture. Mental status consistent with completing the study protocol.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds; received radiation treatment to any site at any time in the past; received chemotherapy for cancer at any time in the past.

How the Study Was Run

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

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

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

It started in 2008-01 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Healing of a Fracture From a Low Energy Fall (time frame: Measured at 16 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 10 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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