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A prospective, multi-center, randomized, parallel controlled clinical cohort study of the efficacy and safety of Desucumab in the treatment of ankylosing spondylitis patients with secondary osteoporosis

A prospective, multi-center, randomized, parallel controlled clinical cohort study of the efficacy and safety of Desucumab in the treatment of ankylosing spondylitis patients with secondary osteoporosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086783
Enrollment
Unknown
Registered
2024-07-10
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankylosing spondylitis osteoporosis

Interventions

Test group:Desucumab
Positive group:Bisphosphonate

Sponsors

Zhejiang Provincial People's Hospital,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Age 20-60 years old; (2) Meet the 1984 New York diagnostic criteria for ankylosing spondylitis or the 2009 ACR/EULAR diagnostic criteria for axial spondylitis; (3) The patient has not changed any biologics in the past 3 months; (4) Meet at least one of the diagnostic criteria for osteoporosis: a, for postmenopausal women and men >50 years of age, bone mineral density (BMD) T-value of lumbar spine and/or hip (total hip and/or neck) = -2.5SD as assessed by DXA; b. Fragility fracture of the hip or vertebral body; c, bone mineral density (BMD) test consistent with bone loss (-2.5<T value <-1 SD) + fragility fracture of the proximal humerus, pelvis or distal forearm; d. Lumbar spine QCT test < 80mg/cm3.

Exclusion criteria

Exclusion criteria: (1) are receiving any bisphosphonate treatment; (2) being treated with Desucumab; (3) is receiving glucocorticoid or any sex hormone therapy; (4) Renal insufficiency, creatinine clearance <35 ml/min; (5) dysphagia and/or acute diseases of the upper digestive tract; (6) Secondary osteoporosis caused by diabetes, long-term untreated hyperthyroidism, or diseases that interfere with bone density testing; (7) Patients with other rheumatic immune diseases; (8) Those deemed unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Bone Mineral Density, BMD;

Secondary

MeasureTime frame
N-terminal propeptide of type 1 precollagen,P1N;ß-Crosslaps, ß-ctx;parathyroid hormone, PTH;Serum Calcium;25-(OH)VitD3;serum receptor activator of NF-?B ligand, RANKL;osteoclastogenesis inhibitory factor, OPG;erythrocyte sedimentation Rate, ESR;C-reactive protein, crp;Ankylosing Spondylitis Disease Activity Score;Validation of the Ankylosing Spondylitis Quality of Life assessment tool;severe adverse reactions, AE SAE;

Countries

P.R. China

Contacts

Public ContactLiya Song

Zhejiang Provincial People's Hospital,

lysong2@163.com+86 136 0662 8626

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026