Ankle Fractures Treated With Teriparatide

What Was Tested

This registered phase 4 trial tested Teriparatide.

It had two arms (groups): Teriparatide Intervention (experimental) and Usual care (no intervention).

Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks.

No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.

The registry classes the interventions as drug.

More on the Plan

Ankle fractures are common in older people, they are very disabling and require either a cast or a boot for treatment and the patients need to use crutches for balance.

Also these fractures commonly result in patients needing a temporary period of residential care.

Teriparatide hormone is one of the new medications used for treating osteoporosis(weak bones), and studies in the USA have reported that Teriparatide hormone treatment can accelerate bone fracture healing time in pelvic fractures.

Other reports also support faster healing time when Teriparatide hormone is used.

Who Took Part

Enrollment: 10 planned participants were the target.

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: Participant is willing and able to give informed consent for participation in the study. Male or Female (women of non-child bearing potential only\*), aged 50 years or above. Ankle fracture Weber type B suitable for conservative treatment in a synthetic cast. The fracture should be less than 10 days old. Able and willing to comply with all study requirements.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: current smokers (both tobacco and electronic cigarettes); chronic renal disease; insulin dependent diabetes mellitus.

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.

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

Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.

It started in 2016-10 with completion listed for 2017-10.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Assessment of healing parameters of the fracture (time frame: Week 1 - Week 13).

It also tracked 2 secondary outcomes, for example Identify the participant's pain during the treatment period and Functional assessment of the ankle using Olerud and Molander questionnaire.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 10 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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