Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

What Was Tested

This registered phase 2 trial tested Abaloparatide.

As well as a total of 24 men in an open-label design will be enrolled as an extension to this study.

It had three arms (groups): Abaloparatide (PM Women) (active comparator), Placebo (PM Women) (placebo comparator) and Abaloparatide (Men) (experimental).

Placebo administered subcutaneously with a pen once daily for 6 months.

The registry classes the interventions as drug.

More on the Plan

In addition, as Tymlos is now approved for treatment in men, the investigators will enroll 24 men aged 55 and over who will treat in an open-label design.

Their responses to teriparatide will be compared to those of untreated men in an ongoing observational study, as well as to the postmenopausal women.

This study has 3 objectives: 1.

In this pilot study the investigators will evaluate surgical outcomes at one year and the primary outcome will be fusion based on CT exam with categories of Fusion/ Indeterminate/ Not fused and this will be compared between groups receiving 6 months of abaloparatide vs. placebo.

Who Took Part

Enrollment: 96 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: Postmenopausal women (defined as \>12 months since last menstrual cycle) OR men. Age of 50 years or older.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: hypersensitivity to abaloparatide; patients with active hypercalcemia or current diagnosis of hyperparathyroidism; history of multiple renal calculi or renal calculus within 2 years.

How the Study Was Run

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

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, care provider, investigator and outcomes assessor.

It started in 2019-08-14 with completion listed for 2027-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Difference in measure of fusion mass bridging from transverse process to transverse process (time frame: one year). Difference in incidence of adverse surgical outcomes (time frame: one year).

It also tracked 2 secondary outcomes, for example Pain assessed by the Numeric Rating Scale and Pain assessed by the Oswestry Disability Index.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Abaloparatide in 96 people.

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

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