Study of Teriparatide in Stress Fracture Healing

What Was Tested

The trial (phase 3) is built around Teriparatide.

Investigation into the use of teriparatide in the treatment of stress fractures.

Primary outcome is healing on MRI, secondary outcomes are pain, time spent in rehabilitation and future stress fractures.

This study will help the investigators understand how to treat stress fractures in the future.

It had two arms (groups): Intervention - Teriparatide Treatment (experimental) and Control - Standard Care (no intervention).

Standard rehabilitation care with additional monitoring to assess healing.

The registry classes the interventions as drug.

More on the Plan

Teriparatide is a drug that is designed to have a similar effect on the body as parathyroid hormone.

Parathyroid hormone is made naturally in the body and is released in response to low calcium levels.

It helps to maintain bone health and repair bone damage.

Who Took Part

The registry lists 136 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Signed informed consent form;. Participant must be aged 18 - 40 years inclusive;. Participant must have a lower limb stress fracture, either unilateral or bilateral, as confirmed via MRI scan;. Undergoing phase 1 or 2 training within an Army training establishment;. Participants able to adhere to the visit schedule and protocol requirements.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: hypersensitivity to the active parathyroid hormone substance or any of the excipients listed in the smpc; pre-existing hypercalcaemia; patients with skeletal malignancies or bone metastases.

How the Study Was Run

Design: randomized, parallel-group and single-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.

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

Only one side, usually the participants, was kept unaware of whether Teriparatide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-12-23 with completion listed for 2022-06.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Radiological healing (time frame: 8 weeks).

It also tracked 7 secondary outcomes, for example Radiological Healing, Time to 'Healing' as a composite assessment, Time from randomisation to discharge from rehabilitation, Pain symptoms on a visual analogue pain scale, Difference in Quality of life and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 136 people.

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.