Rheumatoid Arthritis (RA)NCT07336693
Bone Density Change in Postmenopausal Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA) and Osteoporosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Rheumatoid arthritis is associated with systemic inflammation-mediated bone loss, leading to an increased risk of osteoporosis and fractures, particularly in postmenopausal patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rheumatoid Arthritis (RA), Osteoporosis
- What is being tested?
- Bone Density Test
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective study was conducted using patient data obtained from the electronic medical records of a university hospital over the past five years.
Who may be able to join
- Postmenopausal women with a confirmed diagnosis of rheumatoid arthritis
Who cannot join
- Concomitant inflammatory rheumatic diseases other than RA
- History of malignancy
- Uncontrolled or untreated endocrine or metabolic disorders affecting bone metabolism, such as primary hyperparathyroidism, Cushing's syndrome, severe renal failure, severe hepatic failure
- Incomplete medical records or missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa (IUC)
Istanbul
About this study
Official title: Changes in Bone Mineral Density and the Impact of Therapeutic Approaches in Postmenopausal Patients With Rheumatoid Arthritis
Rheumatoid arthritis is associated with systemic inflammation-mediated bone loss, leading to an increased risk of osteoporosis and fractures, particularly in postmenopausal patients. Although disease-modifying antirheumatic drugs may help mitigate bone loss, comparative longitudinal data on different treatment strategies remain limited. This study aimed to evaluate changes in bone mineral density over time and assess the impact of conventional synthetic and biologic DMARDs, together with anti-osteoporotic therapy, on bone health.
- Conditions
- Rheumatoid Arthritis (RA), Osteoporosis
- Being tested
- Bone Density Test
- Medical subject headings
- Arthritis, Rheumatoid, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Density TestDiagnostic test
BMD values were obtained from DXA scans performed at the lumbar spine (L1-L4), femoral neck, and total femur. All DXA measurements were conducted at the Department of Nuclear Medicine using the same device, a Hologic QDR 4500SL (S/N 45624, Bedford, MA), to ensure methodological consistency. Reference values were based on the NHANES III.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Patients with Rheumatoid Arthritis | Postmenopausal women with a confirmed diagnosis of RA were identified. Postmenopause was defined as ≥12 months of spontaneous amenorrhea or a prior bilateral oophorectomy; women receiving hormone replacement therapy who fulfilled these criteria were also considered postmenopausal. Receives: Diagnostic Test: Bone Density Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density
For each patient, the absolute values and changes in BMD between the two DXA time points for the lumbar spine, femoral neck, and total femur were recorded.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Ugur Cetin, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336693
- Sponsor's protocol ID
- IstanbulUC-BCetin-03
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Joffe I, Epstein S. Osteoporosis associated with rheumatoid arthritis: pathogenesis and management. Semin Arthritis Rheum. 1991 Feb;20(4):256-72. doi: 10.1016/0049-0172(91)90021-q.
PubMed 2042057Theander L, Willim M, Nilsson JA, Karlsson M, Akesson KE, Jacobsson LTH, Turesson C. Changes in bone mineral density over 10 years in patients with early rheumatoid arthritis. RMD Open. 2020 Feb;6(1):e001142. doi: 10.1136/rmdopen-2019-001142.
PubMed 32519976Kroot EJ, Nieuwenhuizen MG, de Waal Malefijt MC, van Riel PL, Pasker-de Jong PC, Laan RF. Change in bone mineral density in patients with rheumatoid arthritis during the first decade of the disease. Arthritis Rheum. 2001 Jun;44(6):1254-60. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-G.
PubMed 11407683
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bone Mineral Density and the Impact of Therapeutic Approaches in Postmenopausal Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07336693
- Acronym / sponsor ID
- IstanbulUC-BCetin-03
- Conditions
- Rheumatoid Arthritis (RA), Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 13 Jan 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.
Rheumatoid arthritis is associated with systemic inflammation-mediated bone loss, leading to an increased risk of osteoporosis and fractures, particularly in postmenopausal patients. Although disease-modifying antirheumatic drugs may help mitigate bone loss, comparative longitudinal data on different treatment strategies remain limited. This study aimed to evaluate changes in bone mineral density over time and assess the impact of conventional synthetic and biologic DMARDs, together with anti-osteoporotic therapy, on bone health.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Patients with Rheumatoid Arthritis | – | Diagnostic Test: Bone Density TestPostmenopausal women with a confirmed diagnosis of RA were identified. Postmenopause was defined as ≥12 months of spontaneous amenorrhea or a prior bilateral oophorectomy; women receiving hormone replacement therapy who fulfilled these criteria were also considered postmenopausal. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective study was conducted using patient data obtained from the electronic medical records of a university hospital over the past five years.
Key inclusion criteria (1 listed)
- Postmenopausal women with a confirmed diagnosis of rheumatoid arthritis
Key exclusion criteria (4 listed)
- Concomitant inflammatory rheumatic diseases other than RA
- History of malignancy
- Uncontrolled or untreated endocrine or metabolic disorders affecting bone metabolism, such as primary hyperparathyroidism, Cushing's syndrome, severe renal failure, severe hepatic failure
- Incomplete medical records or missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Density TestBMD values were obtained from DXA scans performed at the lumbar spine (L1-L4), femoral neck, and total femur. All DXA measurements were conducted at the Department of Nuclear Medicine using the same device, a Hologic QDR 4500SL (S/N 45624, Bedford, MA), to ensure methodological consistency. Reference values were based on the NHANES III. | Diagnostic test | Postmenopausal Patients with Rheumatoid Arthritis |
Primary outcome
Change in Bone Mineral Density
Time frame: 1-2 years
For each patient, the absolute values and changes in BMD between the two DXA time points for the lumbar spine, femoral neck, and total femur were recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 2042057Joffe I, Epstein S. Osteoporosis associated with rheumatoid arthritis: pathogenesis and management. Semin Arthritis Rheum. 1991 Feb;20(4):256-72. doi: 10.1016/0049-0172(91)90021-q.
- Background: PubMed 32519976Theander L, Willim M, Nilsson JA, Karlsson M, Akesson KE, Jacobsson LTH, Turesson C. Changes in bone mineral density over 10 years in patients with early rheumatoid arthritis. RMD Open. 2020 Feb;6(1):e001142. doi: 10.1136/rmdopen-2019-001142.
- Background: PubMed 11407683Kroot EJ, Nieuwenhuizen MG, de Waal Malefijt MC, van Riel PL, Pasker-de Jong PC, Laan RF. Change in bone mineral density in patients with rheumatoid arthritis during the first decade of the disease. Arthritis Rheum. 2001 Jun;44(6):1254-60. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-G.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatoid Arthritis (RA) and Osteoporosis, run by Istanbul University - Cerrahpasa 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bone Mineral Density (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336693, which also lists 3 linked publications.
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 13 Jan 2026.