NCT04091243CompletedPhase 4
Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users
Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Sept 2024
Brief summary (registry, in English)
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 at a much higher bone mineral density (BMD) than postmenopausal osteoporosis, indicating an additional deleterious effect of GC on bone quality. An increased relative risk of vertebral and hip fractures is demonstrated in chronic GC users, with fracture risk proportional to the daily dose of GC. Other studies have also confirmed that intermittent use of high-dose GC and the cumulative GC dose was associated with an augmented risk of osteoporotic fracture. Romosozumab (ROMO) is a humanized monoclonal antibody against sclerostin. The landmark RCT has demonstrated efficacy of ROMO (210mg subcutaneously monthly) over placebo in reducing vertebral fractures by 73% at 12 months in 7180 postmenopausal women with osteoporosis of the hip at entry. Another RCT has demonstrated efficacy of ROMO in reducing vertebral and hip fractures in 4093 post-menopausal women at month 24. There are no data regarding the efficacy of ROMO in GC-induced osteoporosis. Comparative study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet available in the literature. This prompts the current pilot study to compare the efficacy of ROMO with denosumab in high-risk patients receiving long-term GCs.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 12 Sept 2019
- Start date
- 15 Jan 2021
- Primary completion date
- 15 Oct 2023
- Lead sponsor
- Tuen Mun Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT04091243
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 70
- From 15 Jan 2021 to the primary completion date, 15 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents within 24 months of study entry.
Other illness
- Patients with a known past history of atherosclerotic cardiovascular or cerebrovascular disease.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
Lab values
- Patients with serum creatinine level of \>=200umol/L.
Other
- Premenopausal women who plan for pregnancy within 24 months of study entry.
- Patients with unexplained hypocalcemia.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tuen Mun Hospital Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.