Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)

What Was Tested

This registered phase 4 trial tested Teriparatide for osteoporosis and bone density.

It had 1 arm (groups): PTH/Weight-Bearing (experimental).

The registry classes the interventions as drug and other.

More on the Plan

This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities.

Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

An optional extension to 12 months will be offered to all subjects.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18-75 years. Complete SCI - total loss of motor function below level of lesion. Capable of positioning to have DEXA performed. Capable of undertaking the weight-bearing exercise regime. Capable of reading and understanding informed consent document.

The full record lists 13 inclusion and 12 exclusion criteria; among the exclusions: surgical or other intervention resulting in metal or anatomy precluding obtaining dexa and/or mri measurements; other medical conditions that in the opinion of the investigator would preclude the subject from completing the study; history of malignancy.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Teriparatide study: the osteoporosis and bone density participants and staff both knew the treatment.

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

It started in 2009-06 with completion listed for 2012-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: BMD at Left Total Hip (time frame: Baseline to 6 months).

It also tracked 1 secondary outcome, for example P1NP.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Teriparatide in 12 people with osteoporosis and bone density.

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, Osteoporosis and bone density research.