To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide.

It had two arms (groups): one (experimental) and Drug: Alendronate (active comparator).

Administered by subcutaneous injection once a week during treatment phase.

The registry classes the interventions as drug.

More on the Plan

The trial consists of a screening period (4 weeks), an open-label treatment period (up to 48 weeks), and a follow-up period (1 weeks), totaling approximately 53 weeks.

Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.

Who Took Part

493 actual participants took part.

It was open to women only aged from 45 years up to 80 years.

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

Examples of who could join: Postmenopausal women with the ability to live independently (≥45 and ≤80 years);.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: in addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;; patients with other diseases affecting calcium or bone metabolism;; received anti-osteoporosis treatment that does not meet protocol requirements;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-12-03 with completion listed for 2023-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks (time frame: Baseline to 48 Weeks).

It also tracked 4 secondary outcomes, for example Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks, Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks, Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks and Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 493 people.

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

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