Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.

It had eight arms (groups): Placebo (placebo comparator), Alendronate (active comparator), Teriparatide (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

419 actual participants took part.

It was open to women only aged from 55 years up to 85 years.

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

Examples of who could join: Ambulatory, postmenopausal women, aged ≥ 55 to ≤ 85. Low BMD measured by dual energy X-ray absorptiometry (DXA) and assessed by the central imaging vendor (equivalent to T-scores between -2.0 and -3.5).

The full record lists 2 inclusion and 33 exclusion criteria; among the exclusions: history of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; untreated hyper- or hypothyroidism; current hyper- or hypoparathyroidism, hypo- or hypercalcemia.

How the Study Was Run

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

The osteoporosis and bone density 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.

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 2009-06-03 with completion listed for 2011-02-21.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine (time frame: Baseline to 12 months).

It also tracked 10 secondary outcomes, for example Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine, Percent Change From Baseline at Month 6 in BMD of the Total Hip, Percent Change From Baseline at Month 6 in BMD of the Femoral Neck, Percent Change From Baseline at Month 12 in BMD of the Total Hip, Percent Change From Baseline at Month 12 in BMD of the Femoral Neck and Percent Change From Baseline at Month 12 in BMD of the Distal Radius.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 419 people with osteoporosis and bone density.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Osteoporosis and bone density research.