Stem Cell Recruitment in Osteoporosis Therapy

What Was Tested

In this not phased trial, researchers set out to test Teriparatide for osteoporosis and bone density.

Osteoporosis is an important health problem in the rapidly-aging demographic.

Fragility fractures are devastating consequences of osteoporosis.

The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN).

It had three arms (groups): teriparatide (active comparator), Alendronate (active comparator) and calcium and vitamin D (active comparator).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

55 actual participants took part.

It was open to women only aged from 50 years up to 80 years.

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

Examples of who could join: Post-menopausal women aged 50-80 years. T score \< -2.5 at lumbar spine, total hip or femoral neck on dual x-ray absorptiometry (DXA) OR T score \< -1.5 with a personal or family history of fracture.

The full record lists 2 inclusion and 22 exclusion criteria; among the exclusions: previous use of bisphosphonates or teriparatide; current estrogen therapy; any other osteoporosis therapy in the past 6 months; metabolic bone disease other than osteoporosis; body mass index (bmi) \< 18.

How the Study Was Run

The set-up was randomized, single-group and open-label.

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

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-08 with completion listed for 2014-06.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN) (time frame: up to 3 months).

It also tracked 2 secondary outcomes, for example Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups and Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 55 people with osteoporosis and bone density.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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