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

This study has been completed.
Sponsor:
Collaborators:
Crohn's and Colitis Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00114803
First received: June 17, 2005
Last updated: December 4, 2007
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Children's Hospital Boston:

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

Ages Eligible for Study:   8 Years to 22 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114803

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Crohn's and Colitis Foundation
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00114803     History of Changes
Other Study ID Numbers: Calcitonin 1.0, CCFA #249
Study First Received: June 17, 2005
Last Updated: December 4, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Osteoporosis
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014