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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114803
First Posted: June 20, 2005
Last Update Posted: December 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Crohn's and Colitis Foundation
National Institutes of Health (NIH)
Information provided by:
Boston Children’s Hospital
  Purpose
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.

Condition Intervention
Ulcerative Colitis Crohn's Disease Drug: Calcitonin nasal spray (salmon)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by NLM:


Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Bone mineral density at 18 months

Secondary Outcome Measures:
  • Bone mineral density at 9 months

Estimated Enrollment: 66
Study Start Date: January 2004
Study Completion Date: October 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114803


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Crohn's and Colitis Foundation
National Institutes of Health (NIH)
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00114803     History of Changes
Other Study ID Numbers: Calcitonin 1.0
CCFA #249
First Submitted: June 17, 2005
First Posted: June 20, 2005
Last Update Posted: December 5, 2007
Last Verified: April 2007

Keywords provided by Boston Children’s Hospital:
bone mineral density
osteoporosis
osteopenia
children
adolescents
DXA

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents