Teriparatide for Fracture Repair in Humans

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide.

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

The registry classes the interventions as drug.

More on the Plan

Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Who Took Part

It was open to people of any sex aged from 60 years up to 90 years.

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

Examples of who could join: Recent proximal 2-segment humerus fracture (0-8 days post fracture). No surgical treatment at fractured site. Signed informed consent. Postmenopausal female and male patients aged 60 - 85 years. Established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: hypersensitivity to the active substance or to any of the excipients; pre-existing hypercalcemia; metabolic bone diseases (including hyperparathyroidism and paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

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 and investigator.

It started in 2014-06 with completion listed for 2015-09.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Identification of bone and callus patterns in the CT data at the fracture site (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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