Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?

What Was Tested

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

40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks.

Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS).

Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment.

It had two arms (groups): Proximal humeral fracture - intervention (experimental) and Proximal humeral fracture (no intervention).

20 patients will receive standard treatment (physiotherapy).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to women only 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: Proximal humeral fracture. Postmenopausal woman 50 years or older.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: dementia or psychiatric disorder; known malignancy \< 5 years prior to fracture; calcium above reference value.

How the Study Was Run

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

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

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

In this single-blind Teriparatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2010-04 with completion listed for 2014-02.

It ran at 2 sites in Sweden (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment (time frame: 7 weeks).

It also tracked 2 secondary outcomes, for example Function and Pain.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 40 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.