Knee OsteoarthritisNCT07881861
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
An observational study of Knee Osteoarthritis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2026to 10 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul
Alperen Tayfur, +90 507 098 91 91, alptayfur467@gmail.com
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
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.
Measured: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
Secondary outcomes (4)
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.
Measured: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
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.
Measured: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
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.
Measured: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
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.
Measured: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start8 May 2026
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enes Efe Is, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881861
- Sponsor's protocol ID
- 5503
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07881861
- Acronym / sponsor ID
- 5503
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum COMP levels from T0 to T1 comparing denosumab and bisphosphonate groups
Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
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.
Change in serum MMP-3 levels from T0 to T1 comparing denosumab and bisphosphonate groups
Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
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.
4 secondary outcomes
Change in serum COMP levels from T0 to T1 comparing denosumab and control groups
Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
Change in serum MMP-3 levels from T0 to T1 comparing denosumab and control groups
Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
Change in serum COMP levels from T0 to T1 comparing bisphosphonate and control groups
Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
Change in serum MMP-3 levels from T0 to T1 comparing bisphosphonate and control groups
Time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum COMP levels from T0 to T1 comparing denosumab and bisphosphonate groups (time frame: Immediately before and within 0-2 minutes after the 30-minute treadmill walking session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.