Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

What Was Tested

The trial (phase 4) is built around Teriparatide.

This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months.

It had two arms (groups): Teriparatide (experimental) and Controls (other).

Controls receive no treatment with teriparatide.

The registry classes the interventions as diagnostic test, drug, other and procedure.

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 18 years up to 120 years.

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

Examples of who could join: Age ≥18 years.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: previous fracture withon the last 6 months \*patients may be rescreened after the 6 months; previous calciphylaxis; thyroid disturbances not adequately treated based on the opinion by the clinician \*patients may be rescreened after treatment optimization.

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.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2021-12-15 with completion listed for 2026-09-01.

It ran at 4 sites in Denmark (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in bone specific alkaline phosphatase (BSAP) (time frame: Baseline and 18 months).

It also tracked 27 secondary outcomes, for example BMD at the lumbar spine, antebrachium, femoral neck and total hip, Incidence of fragility fractures and vertebral fractures assessed using x-ray of columna or vertebral fracture assessment (VFA), Bone microarchitecture assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT), Volumetric BMD assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT), Bone geometry assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT) and Bone strength assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 48 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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