Effect of Abaloparatide on Lumbar Disc Degeneration

What Was Tested

The trial (phase 2) is built around Abaloparatide.

Low back pain is a major public health issue as the leading cause of disability globally.

Degeneration of intervertebral disc (IVD) disorder is once source of low back pain.

Current treatment options for low back pain secondary to degeneration of intervertebral disc include conservative care, steroid injections, prescription pain medications, physical therapy, or surgery, such as discectomy or laminectomy.

It had two arms (groups): abaloparatide (experimental) and placebo (placebo comparator).

Placebo formulated similarly but without active abaloparatide injected subcutaneously once daily for 90 days.

The registry classes the interventions as drug.

More on the Plan

The investigators will perform a randomized, double blind, placebo controlled proof-of-concept Phase 2 clinical trial of the effect of abaloparatide for the treatment of lumbar degenerative disc disease.

The study team physicians will review pertinent laboratory data, medication history, and problem lists in the potential research participant's medical record to ensure eligibility for the study.

The investigators will also contact the potential research participants by telephone to explain the study in further detail and elicit information not available in the medical record that would affect the potential participant's eligibility to participate in the study.

At the study visit, a study team physician and research coordinator will review the study and consent the research participants.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Single- or two-level DDD at lumbar spine. Oswestry disability index score \> 30. Failed \> 3 months of appropriate non-operative care (i.e. pain medication, local drug injections, physical therapy). Predominant back pain with or without leg pain. Able and willing to comply with follow-up schedule.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: presence of objective motor deficit; symptomatic compressive pathology due to stenosis or disc herniation; any spondylolisthesis.

How the Study Was Run

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

Because people in this Abaloparatide 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.

Neither the participants nor the staff measuring them knew who was on Abaloparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2021-03 with completion listed for 2023-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Change in disability as assessed by ODI, Change in pain as assessed by pain numerical rating scale, Change in disability as assessed by PROMIS-29 score, Change in radiographic markers of Degenerative Disc Disease (DDD) as assessed by absolute difference in Pfirrmann Grading system, Change in radiographic markers of DDD as assessed by average absolute difference in Modic score and Change in radiographic markers of DDD as assessed by Modic score.

What This Means in Plain Language

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

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

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