Phase II Study of Calcitonin for Tumoral Calcinosis

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Children's Memorial Hospital
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004358

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 II

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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)

Children's Memorial Hospital

Investigators

Study Chair:

Craig B. Langman

Children's Memorial Hospital

More Information

No publications provided

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

Keywords provided by National Center for Research Resources (NCRR):

arthritis & connective tissue diseases
rare disease
tumoral calcinosis

Study placed in the following topic categories:

Calcitonin Gene-Related Peptide
Calcinosis
Calcitonin
Vasodilator Agents
Metabolic Diseases
Arthritis

Rare Diseases
Connective Tissue Diseases
Bone Density Conservation Agents
Cardiovascular Agents
Salmon calcitonin
Metabolic Disorder

Additional relevant MeSH terms:

Calcitonin Gene-Related Peptide
Calcium Metabolism Disorders
Calcinosis
Calcitonin
Vasodilator Agents
Metabolic Diseases

Therapeutic Uses
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Agents
Salmon calcitonin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009