Status:
COMPLETED
Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users
Lead Sponsor:
Tuen Mun Hospital
Conditions:
Glucocorticoid-induced Osteoporosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Glucocorticoid (GC) is the main stay of treatment of many rheumatic diseases but is also an important cause of secondary osteoporosis. The long-term use of GCs increases the risk of fragility fracture...
Detailed Description
Glucocorticoid (GC) is the main stay of treatment of many rheumatic diseases but is also an important cause of secondary osteoporosis. The long-term use of GCs increases the risk of fragility fracture...
Eligibility Criteria
Inclusion
- Adults (women or men) \>18 years of age
- Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥5mg/day for ≥12 months.
- High risk of osteoporotic fracture (in subjects \<40 years, personal history of fragility/vertebral fracture, bone mineral density \[BMD\] of the hip/spine Z score ≤ -3.0, loss of BMD \>10% per year or new fracture; in subjects aged ≥40 years, personal history of fragility/vertebral fracture, BMD of the hip/spine T score ≤ -2.5, GC-adjusted 10-year major osteoporotic fracture risk ≥20% or hip fracture risk ≥3% by FRAX \[ie. multiplying risk by 1.15 for the former and 1.20 for the latter when prednisolone ≥7.5mg/day\], or new fracture development).
- 5\. Informed consent from patients. 6. Willing to comply with all study procedures
Exclusion
- Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents within 24 months of study entry.
- Premenopausal women who plan for pregnancy within 24 months of study entry.
- Patients with a known past history of atherosclerotic cardiovascular or cerebrovascular disease.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with unexplained hypocalcemia.
- Patients with serum creatinine level of \>=200umol/L.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04091243
Start Date
January 15 2021
End Date
November 15 2023
Last Update
September 4 2024
Active Locations (1)
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1
Tuen Mun Hospital
Hong Kong, China