VERtebral Fracture Treatment Comparisons in Osteoporotic Women

What Was Tested

This registered phase 4 trial tested Teriparatide.

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

The registry classes the interventions as drug.

Who Took Part

1366 actual participants took part.

It was open to women only aged from 45 years with no upper age limit.

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

Examples of who could join: A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required.

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: history of unresolved skeletal diseases that affect bone metabolism; history of atypical subtrochanteric or diaphyseal femoral fractures; abnormally high or low calcium levels.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-10 with completion listed for 2016-07.

It ran at 103 sites in United States (30), Belgium (9), Canada (9), Italy (7), France (6) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of Participants With New Vertebral Fractures (time frame: Baseline through 24 Months).

It also tracked 11 secondary outcomes, for example Proportion of Participants With Pooled New and Worsening Vertebral Fractures, Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures, Proportion of Participants With Non-Vertebral Fragility Fractures, Proportion of Participants With Major Non-Vertebral Fragility Fractures, Proportion of Participants With New Moderate and/or Severe Vertebral Fractures and Proportion of Participants With New Multiple (2 or More) Vertebral Fractures.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 1366 people.

With 1366 participants it is a large trial for this field.

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.