The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

What Was Tested

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

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

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

PTH (1-84) + placebo alendronate.

PTH (1-84) placebo + alendronate.

The registry classes the interventions as drug.

Who Took Part

The registry lists 75 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.

Examples of who could join: Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: previous/current treatment and medical history.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Parathyroid Hormone (PTH 1-84) and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Parathyroid Hormone (PTH 1-84), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-04 with completion listed for 2010-05.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale (time frame: Baseline and 24 weeks treatment).

It also tracked 1 secondary outcome, for example Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Parathyroid Hormone (PTH 1-84) in 75 people.

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

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.