RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,634
- 试验地点
- 23
- 主要终点
- Incidence of subsequent fracture
研究概览
简要总结
RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years and older (no upper age limit)
- •Sustained a primary fragility fracture (hip/femur, pelvis, clinical spine, humerus, wrist) in the last 12 months
- •Participant must self-identify a regular primary care provider (PCP)
- •Participant must provide a mailing address
- •Participant must plan to remain geographically proximate (able to travel if necessary) to the site from which they are recruited over the next several months
排除标准
- •Exposure to the following medications in the prior 12 months;
- •Actonel or Atelvia (risedronate)
- •Fosamax or Binosto (alendronate)
- •Reclast, Zometa, or Aclasta (zoledronic acid, zoledronate)
- •Boniva or Bondronat (ibandronate)
- •Aredia (pamidronate)
- •Prolia (denosumab)
- •Evenity (romozosumab)
- •Tymlos (abaloparatide)
- •Forteo (teriparatide)
- •Natpara (parathyroid hormone)
- •Evista (raloxifene)
- •Duavee (bazedoxifene-conjugated estrogen)
- •Miacalcin (calcitonin)
- •Diagnosis of the following medical conditions;
- •CKD stage 4 or 5 or on dialysis
- •Multiple myeloma
- •Addison's disease
- •Adrenal insufficiency
- •Enrolled hospice care
- •Solid organ transplant, or expecting a solid organ transplant
- •Bone marrow transplant
- •History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease
- •Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)
- •Pathologic fractures secondary to malignancy or infection
- •Scheduled appointment with a bone health specialist
- •Participant unable to consent on their own (cognitive impairment, dementia, etc.)
- •Currently enrolled in another research study that requires taking medication
研究组 & 干预措施
Enhanced Usual Care Arm
Participants will be mailed education materials and encouraged to follow up with their primary care physician.
干预措施: Enhanced Usual Care Arm (Behavioral)
Augmented-Fracture Liaison Service Arm
Participants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment.
干预措施: Augmented-Fracture Liaison Service Arm (Behavioral)
结局指标
主要结局
Incidence of subsequent fracture
时间窗: 24 months post randomization
Incidence of fracture 24 months post randomization
次要结局
未报告次要终点
研究者
Kenneth Saag, MD, MSc
Professor of Medicine
University of Alabama at Birmingham