Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

What Was Tested

In this phase 4 trial, researchers set out to test Parathyroid Hormone (PTH 1-84) for osteoporosis and bone density.

It had two arms (groups): PTH(1-84) (active comparator) and Strontium Ranelate (active comparator).

The registry classes the interventions as drug.

Who Took Part

82 actual participants took part.

It was open to women only aged from 50 years with no upper age limit.

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

The full record lists 0 inclusion and 33 exclusion criteria; among the exclusions: is the subject female and at or above the age of 50?; has the subject been postmenopausal for more than 5 years - in the judgement of the investigator?; is the subject able to self-inject pth(1-84), or get the injections by a helper?.

How the Study Was Run

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

The osteoporosis and bone density participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

The Parathyroid Hormone (PTH 1-84) group and the comparison group ran side by side rather than switching.

Everyone knew when Parathyroid Hormone (PTH 1-84) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-04 with completion listed for 2009-02.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial (time frame: Baseline and 24 weeks of treatment). Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial (time frame: Baseline and 24 weeks of treatment).

It also tracked 1 secondary outcome, for example Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Parathyroid Hormone (PTH 1-84) in 82 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 Parathyroid Hormone (PTH 1-84) compound page, Osteoporosis and bone density research.