Ulcerative Colitis Clinical Trial
Official title:
Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study
Verified date | April 2007 |
Source | Children's Hospital Boston |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 22 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Boston | Crohn's and Colitis Foundation, National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density at 18 months | |||
Secondary | Bone mineral density at 9 months |
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