Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

What Was Tested

The trial (phase 3) is built around Abaloparatide.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 228 actual participants took part.

It was open to men only aged from 40 years up to 85 years.

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

Examples of who could join: Normal medical history, physical examination, including vital signs, and body mass index. Laboratory tests within the normal range including serum calcium (albumin-corrected), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bmd, defined as having at least 2 radiologically evaluable vertebrae within l1-l4; unevaluable hip bmd or participants who have undergone bilateral hip replacement; fragility fracture within the prior twelve months.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

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 2018-05-03 with completion listed for 2021-08-17.

It ran at 34 sites in United States (22), Poland (9) and Italy (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline in Lumbar Spine BMD at Month 12 (time frame: Baseline, Month 12).

It also tracked 14 secondary outcomes, for example Percent Change From Baseline in Total Hip BMD at Month 12, Percent Change From Baseline in Femoral Neck BMD at Month 12, Percent Change From Baseline in Lumbar Spine BMD at Month 6, Percent Change in Total Hip BMD From Baseline at Month 6, Percent Change From Baseline in Femoral Neck BMD at Month 6 and Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Abaloparatide in 228 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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