µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

What Was Tested

The trial (phase 4) is built around Teriparatide.

The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.

It had two arms (groups): Teriparatide (Forteo) (active comparator) and Zoledronic Acid (Reclast) (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia.

Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to women only aged from 60 years with no upper age limit.

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

Examples of who could join: Age ≥ 60 years. Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months; current alcohol use \> 3 drinks/day; prior radiation therapy to the skeleton.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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 2008-07 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Change in Trabecular Surface-to-curve Ratio (time frame: Change between baseline and 12 months).

It also tracked 1 secondary outcome, for example Percentage of Change in Bone Volume Fraction (BVF).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 33 people.

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, all human trials.