Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Key facts
- Who runs it
- Sisli Hamidiye Etfal Training and Research Hospital
- Where
- Istanbul, TürkiyeSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 105 people, planned
- Started
- 8 May 2026
- Expected to end
- 10 Feb 2027
- Type of study
- Observational, 3 groups
- Record updated
- 20 October 2026
Who can take part
- Age
- 60 years to 80 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- History of total knee arthroplasty or major knee surgery
- New York Heart Association (NYHA) class III-IV heart failure
- Uncontrolled diabetes mellitus or hypertension
- Neurological disease significantly limiting walking
- Cognitive impairment
- Active gout or calcium pyrophosphate deposition (CPPD) attack
- Glomerular filtration rate (eGFR) <30 mL/min
- Inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 80 years old?
Where in Türkiye
- Şişli Hamidiye Etfal Training and Research HospitalIstanbul, TürkiyeContact: Alperen TayfurTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Denosumab Group
Postmenopausal women aged 60-80 years with DEXA-confirmed osteoporosis and clinically and radiographically confirmed knee osteoarthritis who have been regularly receiving denosumab for at least 12 months, with the last dose administered 2-4 months before the study assessment.
- Bisphosphonate Group
Postmenopausal women aged 60-80 years with DEXA-confirmed osteoporosis and clinically and radiographically confirmed knee osteoarthritis who have been regularly receiving the same bisphosphonate for at least 12 months.
- Control Group
Postmenopausal women aged 60-80 years with DEXA-confirmed osteopenia and clinically and radiographically confirmed knee osteoarthritis who are not currently receiving antiresorptive treatment and have either never used antiresorptive treatment or discontinued bisphosphonate treatment at least 5 years ago.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Response of Cartilage Degradation Biomarkers to Acute Mechanical Loading and the Effect of Antiresorptive Therapy in Postmenopausal Women With Mild-to-Moderate Knee Osteoarthritis
- Fit questions
- Built from NCT07881861, who can take part
- Record updated
- 20 October 2026