Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bone mineral density (BMD) changes at the lumbar spine
研究概览
简要总结
The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.
详细描述
There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or adult men (>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.
- •A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.
- •Having received oral bisphosphonate treatment for at least 2 years.
- •Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores < -2.5 or Z scores < -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.
- •Informed consent from patients.
排除标准
- •Patients with previous use of denosumab or teriparatide.
- •Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.
- •Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- •Patients with unexplained hypocalcemia.
- •Patients with serum creatinine level of >=200umol/L.
研究组 & 干预措施
Denosumab
denosumab
干预措施: Denosumab (Drug)
bisphosphonates
continuation of bisphosphonates
干预措施: bisphosphonates (Drug)
结局指标
主要结局
bone mineral density (BMD) changes at the lumbar spine
时间窗: baseline, 6 months and 12 months
次要结局
- New vertebral fractures(12 months)
- BMD changes in the total hip and femoral neck(baseline, 6 months and 12 months)
- adverse events(12 months)
- bone turnover markers(baseline, 6 months and 12 months)
研究者
Chi Chiu Mok
Consultant
Tuen Mun Hospital