Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

What Was Tested

This registered not phased trial tested Teriparatide for hyperparathyroidism.

It had two arms (groups): teriparatide control (active comparator) and Teriparatide Patient (experimental).

Control subject.

Patient with secondary hyperparathyroidism.

The registry classes the interventions as drug.

More on the Plan

Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it.

In these patients, the researchers are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls.

To stimulate the kidneys to activate Vitamin D, the researchers are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours.

This type of parathyroid infusion does not cause side effects.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to women only aged from 40 years up to 59 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 40-59 years. Serum creatinine \< 1.3 and estimated glomerular filtration rate (GRF) \> 60. Parathyroid hormone in the normal range (for U Md lab 12-54 pg/ml). Normal 25-hydroxyvitamin D level (30 ng/ml or higher). For women of childbearing age, non-pregnant (based on negative urine pregnancy test on the morning of the teriparatide infusion).

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: age under 40 and over 59 years; serum creatinine over 1.3 or estimated glomerular filtration rate (gfr) \< 60; abnormal parathyroid hormone (for u md lab, above 65 or below 12 pg/ml).

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the hyperparathyroidism 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 2007-02 with completion listed for 2008-08.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours (time frame: baseline, 4 and 8 hours after start of infusion).

It also tracked 1 secondary outcome, for example The Number of Patients With Mutations in CYP27B1.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Teriparatide in 20 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

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

More context: the Teriparatide compound page, Hyperparathyroidism research.