CalcinosisPhase 2NCT00004358
Phase II Study of Calcitonin for Tumoral Calcinosis
A Phase 2 study testing calcitonin in people with Calcinosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Calcinosis
- What is being tested?
- calcitonin
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1992to not given
- Phase
- Phase 2
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
About this study
OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis.
II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus.
IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
Read the detailed description
PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. Ondansetron premedication and intravenous hydration are also administered.
Patients are followed for disease progression and tumor recurrence.
- Conditions
- Calcinosis
- Being tested
- calcitonin
- Keywords
- arthritis & connective tissue diseases, rare disease, tumoral calcinosis
- Medical subject headings
- Calcinosis, Arthritis, Connective Tissue Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitoninDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startNov 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalcinosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 9 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Craig B. Langman, Study chair, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004358
- Sponsor's protocol ID
- 199/11925
- Other IDs
- NU-477
- Status last verified
- Dec 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Calcitonin for Tumoral Calcinosis
- ClinicalTrials.gov ID
- NCT00004358
- Acronym / sponsor ID
- 199/11925
- Conditions
- Calcinosis
- Keywords
- arthritis & connective tissue diseases, rare disease, tumoral calcinosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- Nov 1992
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis.
II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus.
IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
Detailed description
PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. Ondansetron premedication and intravenous hydration are also administered.
Patients are followed for disease progression and tumor recurrence.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
Craig B. Langman study chair
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing calcitonin in people with Calcinosis, run by National Center for Research Resources (NCRR) 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?
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 24 Jun 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 24 Jun 2005; AzTrials last refreshed its copy on 8 Nov 2026.