Cartilage biomarker response to acute loading in knee OA by antiresorptive treatment status

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study groups postmenopausal women with mild-to-moderate knee OA by antiresorptive treatment status and subjects them to a standardized 30-minute treadmill walk. Blood samples taken just before and within 2 minutes after walking will be analyzed for cartilage degradation biomarkers such as COMP and MMP-3. The goal is to see if the biomarker response to acute mechanical loading differs based on antiresorptive therapy. Eligible participants are between 60 and 80 years old, with osteoporosis or osteopenia, and imaging-confirmed knee OA (K/L grades 2–3). No interventional treatment is being tested; the study observes natural biomarker changes in relation to existing medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Postmenopausal women aged 60-80 years.
* DEXA-confirmed diagnosis of osteoporosis or osteopenia.
* Clinically and radiographically confirmed knee osteoarthritis, with Kellgren-Lawrence grade 2 or 3 in at least one knee.
* Knee MRI performed within the previous 3 months.
* Bilateral hand radiographs performed within the previous 6 months.
* Pain intensity of at least 20 mm on the Visual Analog Scale (VAS) during activity.
* Ability to tolerate the standardized acute mechanical loading protocol consisting of 30 minutes of treadmill walking.
* Non-sarcopenic status according to the STAR protocol.
* Ability to provide written informed consent.

Exclusion Criteria:

* Inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.
* Active gout or calcium pyrophosphate deposition (CPPD) attack.
* History of total knee arthroplasty or major knee surgery.
* Intra-articular knee injection within the previous 12 months.
* Change in antiresorptive therapy within the previous 6 months.
* Previous osteoanabolic therapy.
* Systemic corticosteroid use for ≥3 months at a dose equivalent to ≥5 mg/day of prednisone.
* Glomerular filtration rate (eGFR) \<30 mL/min.
* New York Heart Association (NYHA) class III-IV heart failure.
* Uncontrolled diabetes mellitus or hypertension.
* Neurological disease significantly limiting walking.
* Cognitive impairment.

Where it's running

• Sisli Hamidiye Etfal Training and Research Hospital
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.