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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
Türkiye1 site in 1 countryChoose a country to see its sites
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?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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