Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?

What Was Tested

The trial (phase 4) is built around Teriparatide.

This limitation, known as the "remodeling transient," reflects the "coupling" of bone resorption with formation such that interventions impacting either of these processes lead to compensatory changes of the other.

It had two arms (groups): Daily teriparatide (Forteo) (active comparator) and Monthly cycles of teriparatide followed by raloxifene (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 26 actual participants took part.

It was open to women only aged from 60 years up to 89 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Generally healthy, community-dwelling ambulatory post-menopausal women. Able and willing to sign informed consent. Age 60 to 89. Have osteoporosis defined as follows:. Baseline serum 25(OH)D concentration \> 20 ng/ml and \< 60 ng/ml.

The full record lists 8 inclusion and 29 exclusion criteria; among the exclusions: history of exposure to external beam or implant radiation therapy involving the skeleton; paget's disease or unexplained elevations of alkaline phosphatase; any history of venous thrombosis including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis and superficial phlebitis.

How the Study Was Run

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

The 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.

Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.

It started in 2010-09 with completion listed for 2012-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Serum Markers of Skeletal Turnover (Serum CTX) (time frame: These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits). Serum Markers of Skeletal Turnover (Serum P1NP) (time frame: These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits).

It also tracked 3 secondary outcomes, for example Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months, Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months and Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 26 people.

Its size is small, so on its own it can only give an early look.

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.