rhPTH Therapy for Low Turnover Bone Fragility

What Was Tested

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

The purpose of this study is to determine how treatment with a new medication, recombinant human parathyroid hormone (rhPTH) affects calcium balance and bone strength.

It had 1 arm (groups): rhPTH (experimental).

Subjects will be treated rhPTH for 12 months.

The registry classes the interventions as drug.

More on the Plan

Subjects will have had a bone biopsy to definitively determine low bone turnover.

Subjects and the treating doctor decide that treatment with rhPTH (recombinant human parathyroid hormone) is optimal before admission into the study.

During the study, subjects will have several tests that will clarify how rhPTH is affecting calcium metabolism and bone properties.

To examine the effects of PTH (parathyroid hormone) on calcium metabolism, subjects will be admitted to the GCRC for 3 days in the beginning of the study.

Who Took Part

Enrollment: 2 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: subjects who are pregnant or younger than 20 will be excluded. subjects cannot have osteoporosis.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Parathyroid Hormone (PTH 1-84) study did not mask who received what.

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

It started in 2003-02 with completion listed for 2011-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To describe the acute effects of rhPTH administration on calcium balance.

It also tracked 1 secondary outcome, for example To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Parathyroid Hormone (PTH 1-84) in 2 people with osteoporosis and bone density.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Parathyroid Hormone (PTH 1-84) compound page, Osteoporosis and bone density research.