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NCT00004358 Clinical Trial

Phase II Study of Calcitonin for Tumoral Calcinosis

Calcinosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004358
Other study ID # 199/11925
Secondary ID NU-477
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated June 23, 2005
Start date November 1992

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility PROTOCOL ENTRY CRITERIA:

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• calcitonin

Locations
Country Name City State
United States Children's Memorial Hospital, Chicago Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

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