Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease
Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study
2 other identifiers
interventional
66
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 17, 2005
CompletedFirst Posted
Study publicly available on registry
June 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 5, 2007
April 1, 2007
June 17, 2005
December 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone mineral density at 18 months
Secondary Outcomes (1)
Bone mineral density at 9 months
Interventions
Eligibility Criteria
You may qualify if:
- Low bone mineral density as defined
- Age 8 to 22 years
- Diagnosis of Crohn's disease or ulcerative colitis
You may not qualify if:
- Receiving calcitonin or biphosphonates, androgens or growth hormone
- Steroid induced fracture in the past
- Pregnant
- Diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Crohn's and Colitis Foundationcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2005
First Posted
June 20, 2005
Study Start
January 1, 2004
Study Completion
October 1, 2006
Last Updated
December 5, 2007
Record last verified: 2007-04