PTH and Vibration in OSteoporosis Study

What Was Tested

This registered not phased trial tested Teriparatide.

WBV stimulates muscles and bones.

It had three arms (groups): controlgroup (active comparator), studygroup 1 (experimental) and studygroup 2 (experimental).

The registry classes the interventions as drug and other.

More on the Plan

To study the effects of WBV on muscle function and balance in osteoporosis 5.

Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.

The number of participants in the latter pilot work is reassuringly consistent with the sample size calculations.

Statistical Methods: STATA/SPSS will be used for data analysis.

Who Took Part

The registry lists 35 actual participants took part.

It was open to women only aged from 50 years with no upper age limit.

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

Examples of who could join: Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: women currently taking oral glucocorticoids; women unable to give informed consent; women unable to stand for 2 minutes at a time on the vibration platform.

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.

The Teriparatide group and the comparison group ran side by side rather than switching.

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

It started in 2015-11 with completion listed for 2018-11.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Changes in the Bone microarchitecture at the tibia, Changes in the Bone microarchitecture at the radius, changes in muscle mass, Changes from baseline in the markers of bone resorption, Changes from baseline in the markers of bone formation and Changes in Muscle strength.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 35 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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