Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

What Was Tested

The trial (phase 3) is built around Teriparatide.

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

The registry classes the interventions as drug.

Who Took Part

712 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: Postmenopausal women 45 years or older. No period for at least two years. History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator). Minimum of one moderate spinal bone fracture. Beginning pain level of at least four on an eleven point scale. Bone Mineral Density (BMD) must meet criteria.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: have an active or suspected diseases that affects bone metabolism other than osteoporosis; participants that already know that they will require procedures to repair their spinal bone fractures; abnormal values of certain lab tests.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

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

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2006-06 with completion listed for 2009-06.

It ran at 72 sites in United States (20), Canada (8), Germany (8), Belgium (7), Australia (5) and France (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 20 secondary outcomes, for example Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire, Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire, Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire, Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO), Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) and Number of Participants With Adverse Events (Safety) During 12 Months.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 712 people.

With 712 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.