7 Day Continuous Parathyroid Hormone IV Infusion

What Was Tested

In this early phase 1 trial, researchers set out to test Parathyroid Hormone (PTH 1-84) for hyperparathyroidism and osteoporosis and bone density.

Study consists of an eight day inpatient visit on the General Clinical Research Center.

The investigators' specific aims are to: 1.

It had two arms (groups): Group 1 (experimental) and Group 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Thus, the suppression of 1,25 (OH)2 vitamin D seen in HHM remained unexplained.

In addition to assessing the effects of an infusion of PTHrP and PTH on calcium handling and 1,25(OH)2 vitamin D, the researchers also measured their effects on markers of bone turnover.

Given the clinical observations seen in Hyperparathyroidism (HPT) and HHM, the researchers anticipated that PTH would stimulate both bone resorption and formation, while PTHrP would stimulate bone resorption but inhibit formation.

However, N-terminal propeptide of type 1 procollagen (P1NP) continued to decline even further as is seen in HHM in contrast to HPT.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 24 years up to 35 years.

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

Examples of who could join: Healthy Caucasian, Hispanic or Asian subjects. Males and Females. Ages 24 - 35 years old. Participants in the study will be required to discontinue all vitamins and health food supplements two weeks prior to the study.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: cardiac, hypertensive, vascular, renal (serum creatinine of \>1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease; body mass index (bmi) \> 30,; pregnancy (all women will have a urine pregnancy test performed immediately before starting the study and must not be pregnant).

How the Study Was Run

It was run as a single-group and single-blind study.

In this single-blind Parathyroid Hormone (PTH 1-84) study one party knew the assignments and the other did not.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant.

It started in 2006-09 with completion listed for 2007-12.

It ran at 1 site in United States.

What Was Measured

Researchers chose this as the main measure: Total Serum Calcium (time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete). Ionized Serum Calcium (time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete). Serum Phosphorous (time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete).

It also tracked 9 secondary outcomes, for example 1,25 Vitamin D, Parathyroid Hormone (1-84), Fractional Excretion of Calcium, 24 Hour Urine Calcium, Tubular Maximum for Phosphorous and Serum Amino-terminal of Collagen- (sNTX).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Parathyroid Hormone (PTH 1-84) in 11 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 Parathyroid Hormone (PTH 1-84) compound page, Hyperparathyroidism research, Osteoporosis and bone density research.