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Trial record 2 of 2 for:    "hyperphosphatemic familial tumoral calcinosis" [DISEASE] OR NCT01003223 [ID-NUMBER] OR NCT00004358 [ID-NUMBER]

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: June 24, 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)
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00004358     History of Changes
Other Study ID Numbers: 199/11925
NU-477
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: June 24, 2005
Last Verified: December 2003

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
Vasodilator Agents