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Phase II Study of Calcitonin for Tumoral Calcinosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004358
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by:
National Center for Research Resources (NCRR)
October 18, 1999
October 19, 1999
December 9, 2005
November 1992
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No Changes Posted
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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

Sexes Eligible for Study: All
Child, Adult, Senior
No
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