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OpenTrials
Completed

NCT Number: NCT02062125

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.

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Key information

Conditions

Scleroderma Calcinosis Calcium Metabolism Disorders Connective Tissue Diseases Metabolic Diseases Nutritional and Metabolic Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RWJ Medical School

New Brunswick, New Jersey, 08903, United States

About this study

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).

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult scleroderma subjects with and without calcinosis

Exclusion criteria

  • Subjects unwilling to participate

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders

Acronym: SSc-calcinosis

Important dates

Study start
2012
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2014
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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