Sustaining Skeletal Health in Frail Elderly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Bone Density of the Total Hip
研究概览
简要总结
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
详细描述
Objective
The long term goal is to improve health, well-being and quality of life in the frail long-term care (LTC) elderly population by reducing fractures. The short term goal is to demonstrate efficacy of the non-bisphosphonate denosumab to improve bone mineral density (BMD), a necessary (but not sufficient) pre-condition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium-vitamin D controlled trial to test the efficacy and predictability of the antiresorptive RANK ligand inhibitor, denosumab (60 mg), among a cohort of 212 institutionalized, under-served, frail men and women ≥65 years old in LTC.
Specific Aims:
Aim 1: To evaluate efficacy of denosumab in improving/maintaining bone mineral density. The investigators will measure conventional hip and spine bone mineral density (BMD).
Primary Hypothesis: After 2 years, women and men on denosumab will have greater hip and spine BMD increases.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) ages 65 and older will be considered if:
- •Reside in long-term care institution (nursing home or assisted living facility); and
- •HaveOsteoporosis: (1) by bone density [spine, hip or forearm Bone Mineral Density (BMD) T-score ≤ -2.5]; (2) A previous adult fragility fracture of the spine or hip; or (3) Would be treated based on FRAX® and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of ≥ 20% for a major fracture or ≥ 3% for hip fracture suing femoral neck BMD.
排除标准
- •Institutionalized residents with subacute illnesses who are not expected to survive or who will be discharged in < 2 years.
- •Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table).
- •Those currently on therapy (including bisphosphonate, denosumab, or teriparatide) or who have been on a bisphosphonate for > 1year during the previous 2 years because some bisphosphonates are long acting.
- •Those with a history of hypocalcemia or contraindication for treatment. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses.
- •Those with vitamin D levels < 25ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks; they will be enrolled if the follow-up vitamin D level is 25 ng/mL or more (if after 2 rounds of vitamin D repletion their vitamin D level is not at least 25 ng/mL, they will not be eligible to be randomized into the study).
- •Those on dialysis or with stage 5 chronic kidney disease (eGFR<15ml/min) will be excluded at screening.
- •Those requiring tooth extraction or oral surgery will not be enrolled until cleared by a dentist.
- •Patients will be allowed to continue on glucocorticoids and anticonvulsants because their use is common in this population.
- •Those on glucocorticoids and anticonvulsants will be allowed to continue in the study because their use is common in this population.
- •Those on hormone replacement therapy (HRT), raloxifene, or prescribed protective hip pads by their Primary Care Physician (PCP) will be allowed to participate and continue on these therapies.
- •We will suggest that participants stop long-term calcitonin as it has been discontinued in Europe due to cancer concerns.
研究组 & 干预措施
Women Denosumab
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
干预措施: denosumab (Drug)
Women Denosumab
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
干预措施: Calcium and Vitamin D (Dietary Supplement)
Women Placebo Group
Semi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
干预措施: Placebo (Drug)
Women Placebo Group
Semi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
干预措施: Calcium and Vitamin D (Dietary Supplement)
Men Denosumab
Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
干预措施: denosumab (Drug)
Men Denosumab
Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
干预措施: Calcium and Vitamin D (Dietary Supplement)
Men Placebo Group
Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements)
干预措施: Placebo (Drug)
Men Placebo Group
Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements)
干预措施: Calcium and Vitamin D (Dietary Supplement)
结局指标
主要结局
Bone Density of the Total Hip
时间窗: 24 months
Bone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Bone Density of the Spine
时间窗: 24 months
Bone Mineral Density (BMD) of the spine percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
次要结局
- Distal Radius BMD(24 Months)
- Femoral Neck BMD(24 Months)
- TBS(24 Months)
研究者
Susan L. Greenspan
Professor of Medicine
University of Pittsburgh