Abaloparatide and Pelvic Fracture Healing

What Was Tested

This registered phase 2 trial tested Abaloparatide.

The primary outcome is CT image based evidence of fracture healing.

The secondary aims are pain and physical performance measures at 3 months.

It had two arms (groups): abaloparatide prefilled syringe (active comparator) and Placebo prefilled syringe (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Pelvic fracture rates are higher in women.

Pelvic fractures are most often a result of low-energy trauma, such as a fall from standing height.

Pelvic fractures are the most relevant for this proposed randomized placebo-controlled study.

This fracture is accompanied by severe pain, chronic immobility and loss of function and independence in the elderly.

Who Took Part

Enrollment: 48 actual participants took part.

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.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: persons unable to complete the nrs and other surveys based on assessment by the study doctor; previously (prior to fracture) non-ambulatory subjects; exclusion criteria related to contraindication or intolerance to abaloparatide:.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Abaloparatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-09-17 with completion listed for 2024-04-25.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Participant (percent) reporting narcotic use for pain.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Abaloparatide in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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