Phase II Study of Calcitonin for Tumoral Calcinosis - Full Text View

Phase II Study of Calcitonin for Tumoral Calcinosis

This study has been completed.

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

ChemIDplus related topics:

Calcitonin Calcitonin human 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

Study ID Numbers:	199/11925, NU-477
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004358
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

Metabolic Diseases

Arthritis

Rare Diseases

Connective Tissue Diseases

Metabolic disorder

Salmon calcitonin

Additional relevant MeSH terms:

Calcium Metabolism Disorders

Vasodilator Agents

Therapeutic Uses

Physiological Effects of Drugs

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008