The FOCUM human disease model for development of osteoarthritis

The FOCUM human disease model for development of osteoarthritis - FOCUM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55307

Enrollment

Registered

2019-12-10

Start date

2020-08-12

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Woman, 2) between 50 and 60 years of age, 3) presently using a combined oral contraceptive, and 4) started oral contraceptive use before her 45th.

Exclusion criteria

Exclusion criteria: 1) Already known with OA (self-reported or registered by general practitioner), 2) known with inflammatory rheumatic conditions including gout, psoriatic arthritis or rheumatoid arthritis (self-reported or registered by general practitioner), 3) having contra-indications for MRI (defined as having a heart pacemaker, implantable cardiac defibrillator (ICD), mechanical heart valve, blood vessel prosthesis/stent/coil, metal or device in or on the body which is not removable, a metallic foreign body in the eye, dental prosthesis with a magnetic click system in the jaw or claustrophobic), 4) terminal or mental illness, and 5) inability to give informed consent.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the progression of MRI features for knee OA.	—

Secondary

Measure	Time frame
The secondary outcomes are the development knee OA according to clinical criteria, the development of OA according to the MRI definition, the progression of X-ray features for hand OA and the development of hand OA according to clinical criteria.	—

Countries

Netherlands

Outcome results