The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

What Was Tested

The trial (phase 2) is built around Teriparatide for osteoporosis and bone density.

The researchers are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.

It had two arms (groups): Teriparatide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In a randomized, single-blinded, placebo-controlled trial, the researchers will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density (primary outcome).

Who Took Part

23 actual participants took part.

It was open to women only aged from 30 years up to 70 years.

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

Examples of who could join: Women, age 30-70 years. Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: diseases known to affect bone metabolism; medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year); pregnant and/or breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The osteoporosis and bone density participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

In this single-blind Teriparatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2008-09 with completion listed for 2016-02-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Lumbar Spine Bone Mineral Density (time frame: Baseline and 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 23 people with osteoporosis and bone density.

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, Osteoporosis and bone density research.