Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease

What Was Tested

In this not phased trial, researchers set out to test Calcitonin for gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers.

Patients who participate will receive either calcitonin or placebo and will have their bone mineral density measured at the start, at nine months, and at 18 months of study.

The registry classes the interventions as drug.

More on the Plan

Study end-point will be at 18 months after the continuous administration of nasal calcitonin or placebo and supplements as above.

Bone mineral density will be measured by dual energy X-Ray absorptiometry (DXA) at the beginning of the study, and then at 9 and 18 months.

The study subjects will be evaluated clinically and nutritionally at the beginning of the study, as well as every 3 months for the duration of the study.

Laboratory values relevant to calcium homeostasis and bone turnover will be obtained every 3 months.

Who Took Part

Enrollment: 66 planned participants were the target.

It was open to people of any sex aged from 8 years up to 22 years.

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

Examples of who could join: Low bone mineral density as defined. Age 8 to 22 years.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: receiving calcitonin or biphosphonates, androgens or growth hormone; steroid induced fracture in the past; diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy.

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 Calcitonin and who got the comparison, which limits bias.

Groups ran in parallel: each of the gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers participants stayed in one arm throughout.

Blinding on both sides kept the gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers participants and researchers unaware of who received Calcitonin.

It started in 2004-01 with completion listed for 2006-10.

It ran at 1 site in United States.

What Was Measured

Researchers chose this as the main measure: Bone mineral density at 18 months.

It also tracked 1 secondary outcome, for example Bone mineral density at 9 months.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Calcitonin in 66 people with gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, Gut: IBD (Crohn's, colitis), leaky gut, IBS & ulcers research.