Actively Recruiting

Age: 18Years +
All Genders
ID07504146

The Natural History of Calcium Pyrophosphate Deposition and Gout: An Observational Clinical and Imaging Study - The Orienting Study

Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2026-03-31

450

Participants Needed

1

Research Sites

626 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with gout, calcium pyrophosphate deposition disease (CPPD), and osteoarthritis (OA) to better understand crystal deposits in joints and blood vessels. This observational study aims to track how these deposits change over time and how they relate to standard treatments and cardiovascular complications. The study will compare patients with gout and CPPD to those with OA as a control group. Participants will receive routine care with clinical, laboratory, and imaging assessments every six months, as well as urgent visits when needed. The study includes two phases: the first to measure crystal deposits in joints and blood vessels, and the second to monitor their progression, treatment associations, and cardiovascular risks. Data will be collected from medical records and entered into an electronic form. Enrollment will last three years, with follow-up for up to ten years. During the study, participants will undergo regular ultrasounds, blood tests, and joint assessments at baseline and every six months for up to ten years. Researchers will measure crystal deposits, bone damage, inflammation markers, joint swelling and tenderness, pain, functional disability, and cardiovascular risk. The study will provide long-term insights into disease impact and treatment response, with data collected from routine care visits and medical records.

CONDITIONS

Brief Title

The Orienting Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with CPPD disease according to ACR/EULAR 2023 criteria or with asymptomatic CPPD on ultrasound or X-rays
  • Patients diagnosed with gout according to ACR/EULAR 2015 criteria
  • Patients diagnosed with osteoarthritis according to ACR criteria with no uric acid or calcium pyrophosphate deposits and uric acid < 6 mg/dL
  • Age 18 years or older
  • Able to provide informed consent according to local ethics requirements
Not Eligible

You will not qualify if you...

  • History of other inflammatory joint diseases besides gout, CPPD, or osteoarthritis
  • Unable to provide informed consent according to local ethics requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants undergo standard clinical, laboratory, and imaging assessments at baseline to evaluate crystal deposition and disease characteristics.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants are monitored with scheduled follow-up visits every 6 months for up to 10 years to assess crystal deposition progression, cardiovascular complications, and disease activity.

Follow-up visits every 6 months and additional urgent visits as needed

Trial Site Locations

Total: 1 location

1

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milano, Italy, 20157

Actively Recruiting

Loading map...

Research Team

G

Georgios Filippou, MD

S

Silvia Sirotti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Global ultrasound assessment of structural lesions in osteoarthritis: a reliability study by the OMERACT ultrasonography group on scoring cartilage and osteophytes in finger joints.

H B Hammer, A Iagnocco, A Mathiessen...

https://pubmed.ncbi.nlm.nih.gov/25520476

Reliability of a consensus-based ultrasound score for tenosynovitis in rheumatoid arthritis.

Esperanza Naredo, Maria Antonietta D'Agostino, Richard J Wakefield...

https://pubmed.ncbi.nlm.nih.gov/22984169

Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report.

Alí Duarte-García, Ying Ying Leung, Laura C Coates...

https://pubmed.ncbi.nlm.nih.gov/30770518

Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association.

R Altman, E Asch, D Bloch...

https://pubmed.ncbi.nlm.nih.gov/3741515

Reliability and Diagnostic Accuracy of Radiography for the Diagnosis of Calcium Pyrophosphate Deposition: Performance of the Novel Definitions Developed by an International Multidisciplinary Working Group.

Silvia Sirotti, Fabio Becce, Luca M Sconfienza...

https://pubmed.ncbi.nlm.nih.gov/36122187