PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)

What Was Tested

The trial (phase 1, phase 2) is built around Teriparatide.

Fragility fractures are common in older adults with weakened bone.

It had two arms (groups): Teriparatide (experimental) and Non-treatment (no intervention).

No treatment control arm.

The registry classes the interventions as drug.

More on the Plan

Teriparatide, recombinant parathyroid hormone (1-34), is an anabolic agent authorized in Canada for the treatment of severe osteoporosis.

Once-daily administration preferentially stimulates osteoblastic over osteoclastic activity, producing net new bone formation.

Clinical evidence in acute fracture healing is limited and mixed.

A randomized trial in distal radius fractures reported shorter time to cortical bridging, and systematic reviews report positive signals in delayed union and non-union.

Who Took Part

The registry lists 54 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: Diabetes (insulin dependent or non-insulin dependent). Renal dysfunction (abnormal creatinine or eGFR that does not meet criteria for "severe impairment" outlined in.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: current smoker; smoking history (more than six months consecutively within the last 10 years); peripheral neuropathy.

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.

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 2027-03-15 with completion listed for 2030-12-16.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Participant recruitment rate (time frame: 2 years).

It also tracked 11 secondary outcomes, for example Treatment fidelity, Participant retention rate, Consent Rate, Barriers to trial implementation, Time to fracture union and Non-union.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Teriparatide in 54 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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