Rheumatoid Arthritis with Achieved Disease Activity Target and Postmenopausal Osteoporosis
Conditions
Interventions
csDMARD combined with denosumab treatment group:None
csDMARD treatment group:None
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Meeting the 1987 American College of Rheumatology (ACR) or 2010 ACR/ European League Against Rheumatism (EULAR) classification criteria of RA; 2) Postmenopausal women; 3) Lumbar or hip bone mineral density (BMD): T=-2.5; 4) RA duration >6 months; 5) Clinical disease activity index (CDAI) =3.3; 6) Rheumatoid factor or anti-cyclic citrullinated peptide (anti-CCP) antibody positive; 7) Receiving conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) at a stable dose for =3 months; Low-dose glucocorticoid (GC) (prednisone equivalent dose =10 mg/ day) for a stable dose of =4 weeks are allowed. 8) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Use of any biological-disease-modifying antirheumatic drugs (bDMARDs) or JAK inhibitors within 6 months before enrollment; 2) Anti-PMOP therapy with denosumab, bisphosphonates or parathyroid hormone within 12 months before enrollment; 3) Hypersensitivity to denosumab; 4) Hypocalcemia; 5) Complicated with serious heart and brain diseases or diseases that affect their survival: such as patients with known malignant tumors, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack, refractory hypertension, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in BMD at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of change in BMD at 6 months;Levels of change in modified total Sharp score (mTSS) assessed at 12 months;Changes from baseline in joint space stenosis (JSN) score at 12 months;Change from baseline in CDAI score at 12 months;Change from baseline in simplified disease Activity Index (SDAI) at 12 months;Change from baseline in disease activity score 28 (DAS28) at 12 months;Changes in bone turnover markers (BTMs) from baseline at 6 and 12 months; | — |
Countries
China
Contacts
Public ContactZhang Zhuoli
Peking University First Hospital
Outcome results
None listed