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NCT07881861
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Conditions: Knee Osteoarthritis
Sex: Female
Ages: 60 Years – 80 Years
Healthy volunteers: No
Enrollment: 105
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Location: Sisli Hamidiye Etfal Training and Research Hospital Istanbul Istanbul
Summary
This study evaluates how acute mechanical loading affects cartilage degradation biomarkers in postmenopausal women with mild-to-moderate knee osteoarthritis. Participants will be grouped according to their existing antiresorptive treatment status: denosumab users, bisphosphonate users, and a control group. All participants will undergo a 30-minute treadmill walking session at a comfortable and tolerated speed. Blood samples will be collected immediately before and within 0-2 minutes after walking to measure changes in cartilage degradation biomarkers, including cartilage oligomeric matrix protein (COMP) and matrix metalloproteinase-3 (MMP-3). The study aims to determine whether the biomarker response to acute mechanical loading differs according to antiresorptive treatment status.
Eligibility Criteria
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) \
Source: ClinicalTrials.gov (NCT07881861). StuddyBuddy aggregates publicly available trial information.