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RecruitingNCT07881861Updated Oct 20, 2026

Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status

An observational study in Knee Osteoarthritis, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 20, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
105
Ages
60 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's planned enrollment of 105 is close to the median of 100 across 484 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 113 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Postmenopausal women aged 60-80 years with clinically and radiographically confirmed knee osteoarthritis who meet the protocol-defined eligibility criteria. Participants are categorized according to their existing antiresorptive treatment status into denosumab, bisphosphonate, and control groups.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
105 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Change in serum COMP levels from T0 to T1 comparing denosumab and bisphosphonate groups

    Change in serum cartilage oligomeric matrix protein (COMP) levels from immediately before acute mechanical loading (T0) to immediately after the loading protocol (T1), comparing participants receiving denosumab with those receiving bisphosphonate treatment.

    Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session

  2. Change in serum MMP-3 levels from T0 to T1 comparing denosumab and bisphosphonate groups

    Change in serum matrix metalloproteinase-3 (MMP-3) levels from immediately before acute mechanical loading (T0) to immediately after the loading protocol (T1), comparing participants receiving denosumab with those receiving bisphosphonate treatment.

    Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session

Secondary outcomes

  1. Change in serum COMP levels from T0 to T1 comparing denosumab and control groups

    Change in serum cartilage oligomeric matrix protein (COMP) levels from immediately before acute mechanical loading (T0) to immediately after the loading protocol (T1), comparing participants receiving denosumab with the control group not receiving current antiresorptive treatment.

    Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session

  2. Change in serum MMP-3 levels from T0 to T1 comparing denosumab and control groups

    Change in serum matrix metalloproteinase-3 (MMP-3) levels from immediately before acute mechanical loading (T0) to immediately after the loading protocol (T1), comparing participants receiving denosumab with the control group not receiving current antiresorptive treatment.

    Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session

  3. Change in serum COMP levels from T0 to T1 comparing bisphosphonate and control groups

    Change in serum cartilage oligomeric matrix protein (COMP) levels from immediately before acute mechanical loading (T0) to immediately after the loading protocol (T1), comparing participants receiving bisphosphonate treatment with the control group not receiving current antiresorptive treatment.

    Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session

  4. Change in serum MMP-3 levels from T0 to T1 comparing bisphosphonate and control groups

    Change in serum matrix metalloproteinase-3 (MMP-3) levels from immediately before acute mechanical loading (T0) to immediately after the loading protocol (T1), comparing participants receiving bisphosphonate treatment with the control group not receiving current antiresorptive treatment.

    Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session

07

Study locations

1 of 1 sites recruiting
  • Sisli Hamidiye Etfal Training and Research Hospital
    Istanbul, Istanbul, Turkey (Türkiye)
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07881861
Responsible party
Enes Efe Is (Associate Professor, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Oct 20, 2026
Start date
May 8, 2026
Primary completion
Feb 10, 2027 (estimated)
Completion
Feb 10, 2027 (estimated)
Last update
Oct 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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