Phase II Study of Calcitonin for Tumoral Calcinosis

This study has been completed.
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004358
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2003

October 18, 1999
June 23, 2005
November 1992
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Complete list of historical versions of study NCT00004358 on ClinicalTrials.gov Archive Site
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Phase II Study of Calcitonin for Tumoral Calcinosis
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Calcinosis
Drug: calcitonin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
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PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required

Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004358
199/11925, NU-477
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National Center for Research Resources (NCRR)
Ann & Robert H Lurie Children's Hospital of Chicago
Study Chair: Craig B. Langman Ann & Robert H Lurie Children's Hospital of Chicago
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP