Renal Osteodystrophy: An Individual Management Approach

What Was Tested

The trial (not phased) is built around Teriparatide.

Renal osteodystrophy (ROD) represents the bone histologic abnormalities resulting from loss of renal function.

It had four arms (groups): Control, low turnover (no intervention), Treatment, low turnover (experimental), Control, high turnover (no intervention) and Treatment, high turnover (experimental).

No intervention in low turnover osteoporosis control group.

Low turnover osteoporosis group treated with teriparatide and cinacalcet.

No intervention in high turnover osteoporosis control group.

The registry classes the interventions as drug.

Who Took Part

The registry lists 141 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Aged 21 years or older;. Chronic maintenance dialysis of at least 3 months' duration;. Willingness to participate in the study;. Normal serum calcium.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: pregnancy or breast feeding;; clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections); chronic alcoholism and/or drug addiction;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 2015-07-01 with completion listed for 2021-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip (time frame: One Year (at baseline and one year)).

It also tracked 4 secondary outcomes, for example Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT), Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH), Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP) and Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 141 people.

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

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