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A Prospective Observational Study on Early Anti-Osteoporosis Treatment in Connective Tissue Disease Patients with Osteopenia During Glucocorticoid Therapy

A Prospective Observational Study on Early Anti-Osteoporosis Treatment in Connective Tissue Disease Patients with Osteopenia During Glucocorticoid Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111567
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Connective tissue diseases

Interventions

Anti-osteoporosis Treatment Group (Calcium Supplements + Vitamin D + Bisphosphonates / Denosumab):None
Basic Treatment Group (Calcium Supplements + Vitamin D ):None

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years, regardless of gender; 2. Meeting the diagnostic criteria for various CTD diseases (such as Primary Sjögren's Syndrome 2002 International Classification Criteria or 2016 ACR/EULAR Classification Criteria; Mixed Connective Tissue Disease Alarcón-Segovia criteria or Kahn criteria; Rheumatoid Arthritis 2010 ACR/EULAR Classification Criteria; Inflammatory Myopathy Bohan/Peter classification criteria; Systemic Lupus Erythematosus 2012 SLICC criteria or 2019 ACR/EULAR classification criteria); 3. Started using glucocorticoids [>=7.5 mg/day of prednisone (or equivalent)] along with basic treatment drugs (calcium, vitamin D) within the past 2 weeks, or glucocorticoids [>=7.5 mg/day of prednisone (or equivalent)] with basic treatment (calcium, vitamin D) and anti-osteoporosis drugs (bisphosphonates, zoledronic acid, or denosumab); 4. Baseline bone mineral density DXA scan (lumbar spine L1-L4 or hip): T-score between -1.0 and -2.5 (osteopenia).

Exclusion criteria

Exclusion criteria: 1. Combined hyperparathyroidism, Paget's disease of bone, osteomalacia; 2. Use of other anti-osteoporosis drugs (such as raloxifene, teriparatide); 3. Participation in any clinical trial within 3 months prior to screening.

Design outcomes

Primary

MeasureTime frame
Osteoporosis Progression Rate;Incidence of New-Onset Fractures;

Secondary

MeasureTime frame
Lumbar Spine BMD Decline Rate;Hip BMD Decline Rate;

Countries

China

Contacts

Public ContactZhao Like

Beijing Hospital

likezhao@126.com+86 159 1111 9080

Outcome results

None listed

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