- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114803
Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease
December 4, 2007 updated by: Boston Children's Hospital
Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 calcium and vitamin D) with that of placebo nasal spray (plus oral supplements of age-appropriate doses of calcium and vitamin D) in maintaining or improving bone mineral density.
Study subjects will be 8 to 22 year old patients with the diagnosis of inflammatory bowel disease (ulcerative colitis and Crohn's disease) and low bone mineral density defined as DXA z score lower than -1.0 SD.
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.
Study Type
Interventional
Enrollment
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bone mineral density at 18 months
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Secondary Outcome Measures
Outcome Measure |
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Bone mineral density at 9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
June 17, 2005
First Submitted That Met QC Criteria
June 17, 2005
First Posted (Estimate)
June 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 5, 2007
Last Update Submitted That Met QC Criteria
December 4, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Physiological Effects of Drugs
- Vasodilator Agents
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcitonin
- Salmon calcitonin
- Calcitonin Gene-Related Peptide
- Katacalcin
Other Study ID Numbers
- Calcitonin 1.0
- CCFA #249
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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