A Comparison of PF708 and Forteo in Osteoporosis Patients

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide.

The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.

It had two arms (groups): Teriparatide (PF708) (experimental) and Teriparatide (Forteo) (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, multi-center study conducted in the United States.

Men and women with osteoporosis will be enrolled in a parallel-group, open-label study design to compare the effects of PF708 and Forteo after 24 weeks of treatment.

Half of the subjects will be randomized to receive PF708, and the other half will be randomized to receive Forteo.

Who Took Part

181 actual participants took part.

It was open to people of any sex aged from 30 years up to 85 years.

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

Examples of who could join: If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women. If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men. Able to use the pen injection device correctly. Able to understand and sign the written Informed Consent Form (ICF).

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening; any current or prior human pth-derived products (e.g., forteo, teribone, natpara), including for investigational purposes; immobility due to severe or chronically disabling conditions (e.g., stroke, parkinson's disease, multiple sclerosis).

How the Study Was Run

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

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2016-12 with completion listed for 2018-05.

It ran at 26 sites in United States (26).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Blood levels of anti-drug antibody (ADA) against teriparatide (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example Mean percentage change in lumbar-spine bone mineral density (BMD), Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP), Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX), Plasma maximum concentration (Cmax) of teriparatide and Plasma area-under-the-curve (AUC) of teriparatide.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 181 people.

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.