- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07336693
Bone Density Change in Postmenopausal Rheumatoid Arthritis
January 2, 2026 updated by: Burak Ugur Cetin, Istanbul University - Cerrahpasa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
82
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Istanbul University - Cerrahpasa (IUC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Postmenopausal women with a confirmed diagnosis of rheumatoid arthritis
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1-2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Theander 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.
- Kroot 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2025
Primary Completion (Actual)
September 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
January 2, 2026
First Submitted That Met QC Criteria
January 2, 2026
First Posted (Actual)
January 13, 2026
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 2, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Metabolic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Bone Diseases, Metabolic
- Nutritional and Metabolic Diseases
- Skin and Connective Tissue Diseases
- Osteoporosis
- Arthritis, Rheumatoid
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Bone Density
Other Study ID Numbers
- IstanbulUC-BCetin-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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