An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

What Was Tested

This registered phase 3 trial tested Teriparatide.

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 436 actual participants took part.

It was open to women only aged from 55 years up to 90 years.

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

Examples of who could join: Postmenopausal women, aged ≥ 55 to ≤ 90. Received oral bisphosphonate therapy for at least 3 years immediately prior to screening. BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck. History of nonvertebral fracture after age 50, or vertebral fracture.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: vitamin d insufficiency, defined as 25 (oh) vitamin d levels \< 20 ng/ml, as determined by the central laboratory; current hyper- or hypocalcemia; current, uncontrolled hyper- or hypothyroidism.

How the Study Was Run

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

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

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

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 2013-01-31 with completion listed for 2015-05-14.

It ran at 50 sites in Denmark (7), Spain (6), United Kingdom (6), United States (5), Canada (5) and Czechia (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) (time frame: Baseline, month 6 and month 12).

It also tracked 14 secondary outcomes, for example Percent Change From Baseline in Total Hip BMD at Month 6, Percent Change From Baseline in Total Hip BMD at Month 12, Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6, Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12, Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 and Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 436 people.

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.