Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial

What Was Tested

The paper reports a study of Parathyroid Hormone (PTH 1-84) in the context of osteoporosis and bone density, published as a randomized controlled trial.

To determine the safety of PTH and its effect on the incidence of vertebral fractures in postmenopausal women with osteoporosis.

Why It Was Studied

Baseline serum PTH and vitamin D levels were not measured.

Many patients discontinued the trial prematurely.

Who Took Part

The abstract describes 2532 women taking part.

By PubMed's age tags, the people studied were middle-aged adults, women only.

2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.

Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and parallel-group study.

Because people in this Parathyroid Hormone (PTH 1-84) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the women and researchers unaware of who received Parathyroid Hormone (PTH 1-84).

The comparison arm used a placebo, so changes seen with Parathyroid Hormone (PTH 1-84) could be set against what happens without it.

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

18-month, randomized, double-blind, placebo-controlled, parallel-group study.

168 centers in 9 countries.

New or worsened vertebral fractures (primary outcome) and changes in bone mineral density and safety (secondary outcomes).

What Was Measured

Baseline serum PTH and vitamin D levels were not measured.

PubMed files the paper under topics including Alkaline Phosphatase, Biomarkers, Bone Density, Hypercalcemia, Hypercalciuria, Incidence and Lumbar Vertebrae.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Parathyroid Hormone (PTH 1-84) in 2532 women in people with osteoporosis and bone density.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (Annals of internal medicine), a journal based in United States.

More context: the Parathyroid Hormone (PTH 1-84) compound page, Osteoporosis and bone density research.