Phase II Study of Calcitonin for Tumoral Calcinosis - Tabular View

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Phase II Study of Calcitonin for Tumoral Calcinosis

This study has been completed.

Study NCT00004358. Last updated on June 23, 2005. Information provided by National Center for Research Resources (NCRR)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Phase II Study of Calcitonin for Tumoral Calcinosis

Official Title ^†

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Calcinosis

Intervention ^†

Drug: calcitonin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

November 1992

Completion Date

Eligibility Criteria ^†

PROTOCOL ENTRY CRITERIA:

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00004358

Organization ID

199/11925

Secondary IDs ^††

NU-477

Study Sponsor ^†

National Center for Research Resources (NCRR)

Collaborators ^††

Children's Memorial Hospital

Investigators ^†

Study Chair:

Craig B. Langman

Children's Memorial Hospital

Information Provided By

National Center for Research Resources (NCRR)

Verification Date

December 2003

First Received Date ^†

October 18, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.