Bone Density Change in Postmenopausal Rheumatoid Arthritis

NCT07336693 — Completed, 82 participants, Istanbul University - Cerrahpasa

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Changes in Bone Mineral Density and the Impact of Therapeutic Approaches in Postmenopausal Patients With Rheumatoid Arthritis

Registry	NCT07336693
Status	Completed
Study type	Observational
Enrollment	82 (Actual)
Sponsor	Istanbul University - Cerrahpasa (Other)
Conditions	Rheumatoid Arthritis (RA), Osteoporosis
Interventions	Bone Density Test (Diagnostic test)
Dates	start 2025-06-01, primary completion 2025-09-01, completion 2025-12-01, first posted 2026-01-13, last updated 2026-01-13
Locations	1 site in Turkey (Türkiye)

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Postmenopausal Patients with Rheumatoid Arthritis		Diagnostic Test: Bone Density Test	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 (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.

+Outcome measures

Primary outcomes

Change in Bone Mineral Density [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.

+Eligibility

Sex: Female

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

+Locations (1)

Facility	City	Country	Status
Istanbul University - Cerrahpasa (IUC)	Istanbul	Turkey (Türkiye)

+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. PMID 2042057
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. PMID 32519976
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. PMID 11407683