A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen

What Was Tested

This registered phase 1 trial tested Teriparatide.

The purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.

It had two arms (groups): ZP-PTH Patch (experimental) and FORTEO(R) Pen (active comparator).

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to determine which of two delivery methods of PTH is preferred by patients after 14 days of use for each.

Patient preference will be determined by means of patient questionnaires at the end of each treatment period and a final questionnaire after both treatment periods are complete.

Adverse events will also be collected.

Who Took Part

The registry lists 24 planned participants were the target.

It was open to women only aged from 55 years up to 85 years.

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

Examples of who could join: Postmenopausal with prior diagnosis of osteoporosis.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: previous use of teriparatide; history of paget's disease.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Each person switched between Teriparatide and the comparison at some point, usually with a gap in between.

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 2015-06 with completion listed for 2015-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Overall Preference (time frame: 28 days).

It also tracked 1 secondary outcome, for example Safety (adverse events).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teriparatide in 24 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.