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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis underlying this study is that nasally administered calcitonin will stabilize or improve bone mineral density in young patients with ulcerative colitis or Crohn's disease. 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. Participants will also receive age appropriate doses of vitamin D and calcium supplements. Other serological measures of vitamin D status will be obtained every 3 months during the study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborators: Crohn's and Colitis Foundation; National Institutes of Health (NIH)
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin; Salmon calcitonin

Criteria

Inclusion Criteria:

• Low bone mineral density as defined

• Age 8 to 22 years

• Diagnosis of Crohn's disease or ulcerative colitis

Exclusion Criteria:

• Receiving calcitonin or biphosphonates, androgens or growth hormone

• Steroid induced fracture in the past

• Pregnant

• Diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy