Back to resultsPhase II Study of Calcitonin for Tumoral Calcinosis
Primary Purpose
Calcinosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
calcitonin
Sponsored by
About this trial
This is an interventional treatment trial for Calcinosis focused on measuring arthritis & connective tissue diseases, rare disease, tumoral calcinosis
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required
Sites / Locations
- Children's Memorial Hospital, Chicago
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004358
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00004358
Brief Title
Phase II Study of Calcitonin for Tumoral Calcinosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
November 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcinosis
Keywords
arthritis & connective tissue diseases, rare disease, tumoral calcinosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
9 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
calcitonin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig B. Langman
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Memorial Hospital, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
12. IPD Sharing Statement
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Phase II Study of Calcitonin for Tumoral Calcinosis
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