Daily nasal spray of hPTH(1-34) for 3 months increases bone mass in osteoporotic subjects: a pilot study

What Was Tested

This randomized controlled trial paper looks at Teriparatide in the context of osteoporosis and bone density.

Although intermittent parathyroid hormone (PTH) injection can lead to strong anabolic effects on bone, daily subcutaneous injection is a disadvantage for patient acceptance.

The researchers have developed a nasal spray formula of parathyroid peptide [hPTH(1-34)] with peak serum hPTH(1-34) concentrations by nasal spray of 1,000 microg similar to those by subcutaneous injections of 20 microg hPTH(1-34).

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, both men and women.

Ninety osteoporotic subjects age 52-84 years (mean 66.5 years) were randomly assigned to receive either 250 microg (PTH250, n=31), 500 microg (PTH500, n=30), or 1,000 microg (PTH1000, n=29) of daily nasal hPTH(1-34) spray for 3 months.

How the Study Was Run

The researchers set it up as a randomized, open-label and pilot study.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Being open-label, the Teriparatide study did not mask who received what.

It is described as a pilot, a small early test of whether a larger Teriparatide study would be practical.

The timeline in the abstract includes 3 months.

What Was Measured

PubMed files the paper under topics including Bone Density, Bone Remodeling, Lumbar Vertebrae, Osteocalcin, Osteoporosis, Osteoporosis, Postmenopausal and Patient Compliance.

What This Means in Plain Language

The paper is a randomized, open-label and pilot study of Teriparatide in people with osteoporosis and bone density over 3 months.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2006 (Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA), a journal based in England.

More context: the Teriparatide compound page, Osteoporosis and bone density research.