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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Calcinosis
 Drug: calcitonin
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 9
Study Start Date: November 1992
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004358

Locations
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Study Chair: Craig B. Langman Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004358     History of Changes
Other Study ID Numbers: 199/11925, NU-477
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
arthritis & connective tissue diseases
rare disease
tumoral calcinosis

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013