Ulcerative ColitisNCT00114803
Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease
A study testing Calcitonin nasal spray (salmon) in people with Ulcerative Colitis and Crohn's Disease, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Calcitonin nasal spray (salmon)
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Low bone mineral density as defined
- Age 8 to 22 years
- Diagnosis of Crohn's disease or ulcerative colitis
Who cannot join
- Receiving calcitonin or biphosphonates, androgens or growth hormone
- Steroid induced fracture in the past
- Pregnant
- Diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Calcitonin nasal spray (salmon)
- Keywords
- bone mineral density, osteoporosis, osteopenia, children, adolescents, DXA
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin nasal spray (salmon)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density at 18 months
Secondary outcomes (1)
Bone mineral density at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2005 (estimated)
- Study startJan 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114803
- Sponsor's protocol ID
- Calcitonin 1.0
- Other IDs
- CCFA #249
- Status last verified
- Apr 2007
- First submitted
- 17 Jun 2005
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00114803
- Acronym / sponsor ID
- Calcitonin 1.0
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- bone mineral density, osteoporosis, osteopenia, children, adolescents, DXA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, National Institutes of Health (NIH)
- Study start
- Jan 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Low bone mineral density as defined
- Age 8 to 22 years
- Diagnosis of Crohn's disease or ulcerative colitis
Key exclusion criteria (4 listed)
- Receiving calcitonin or biphosphonates, androgens or growth hormone
- Steroid induced fracture in the past
- Pregnant
- Diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitonin nasal spray (salmon) | Drug | – |
Primary outcome
Bone mineral density at 18 months
1 secondary outcome
Bone mineral density at 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitonin nasal spray (salmon) in people with Ulcerative Colitis and Crohn's Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density at 18 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2007.