Calcinosis in a Single-Center Scleroderma Population


This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis 2) to identify common complications associated with scleroderma-related calcinosis. .

Full Title of Study: “A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 31, 2022

Detailed Description

This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis). 2) view common complications associated with calcinosis. Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.

Clinical Trial Outcome Measures

Primary Measures

  • risk factors and outcomes in scleroderma calcinosis
    • Time Frame: 10 years
    • This is an observational study of scleroderma calcinosis to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis during this time period. We will assess for increased burden of calcinosis with associated musculoskeletal complications from calcinosis over 10 years. No additional intervention will be delivered, other than standard of care for this complication.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult scleroderma subjects with and without calcinosis Exclusion Criteria:

  • Subjects unwilling to participate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vivien Hsu, M.D., Professor of Medicine – Rutgers, The State University of New Jersey

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