Bone Density Change in Postmenopausal Rheumatoid Arthritis

NCT ID: NCT07336693

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis (RA) Osteoporosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Bone Density Test

Intervention Type DIAGNOSTIC_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.

Interventions

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Bone Density 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Burak Ugur Cetin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University - Cerrahpasa (IUC)

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 2042057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32519976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11407683 (View on PubMed)

Other Identifiers

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IstanbulUC-BCetin-03

Identifier Type: -

Identifier Source: org_study_id

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