Status:
COMPLETED
Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Crohn's and Colitis Foundation
National Institutes of Health (NIH)
Conditions:
Ulcerative Colitis
Crohn's Disease
Eligibility:
All Genders
8-22 years
Phase:
NA
Brief 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 p...
Detailed Description
This is an institutional, randomized, placebo-controlled, double-blind clinical trial to compare the efficacy of intranasally administered calcitonin (plus oral supplements of age-appropriate doses of...
Eligibility Criteria
Inclusion
- Low bone mineral density as defined
- Age 8 to 22 years
- Diagnosis of Crohn's disease or ulcerative colitis
Exclusion
- Receiving calcitonin or biphosphonates, androgens or growth hormone
- Steroid induced fracture in the past
- Pregnant
- Diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00114803
Start Date
January 1 2004
End Date
October 1 2006
Last Update
December 5 2007
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115