Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Percent Change in Lumbar Spine Areal BMD by DXA
研究概览
简要总结
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).
The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.
Funding Source: FDA Office of Orphan Products Development (OOPD).
详细描述
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.
Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.
- •(Premenopausal status is no longer be required for entry.)
排除标准
- •Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal
- •Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL
- •Pregnancy: urine pregnancy test must be negative
研究组 & 干预措施
Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.
干预措施: Denosumab (Drug)
结局指标
主要结局
Percent Change in Lumbar Spine Areal BMD by DXA
时间窗: Baseline and 12 months
Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).
次要结局
- Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months(Baseline and 24 months)
研究者
Elizabeth Shane
Professor of Medicine
Columbia University