Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114803
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2005-06-17
Brief Title:
Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns 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
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 Crohns disease and low bone mineral density defined as DXA z score lower than -10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCFA 249 | None | None | None |