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临床试验/NCT02534714
NCT02534714已完成不适用

Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016

OSF Healthcare System1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
460
试验地点
1
主要终点
(Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level

研究概览

简要总结

The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.

详细描述

Bone Health is becoming of great concern in the population > 50 years old in the past several decades. Literature review has detected a high incidence of patients with hypovitaminosis D and back pain. Vitamin D Deficiency is in all races, age groups, and ethnic backgrounds affecting greater than one billion people worldwide1. There is a higher incidence of Vitamin D Deficiency noted in the northern states.

Adequate Vitamin D is essential in bone health and muscle function. It also has been reported to have positive effects on decreasing myopathy and /or musculoskeletal pain. Vitamin D has been shown to have a protective effect on fracture risk by providing increased bone matrix and on fall prevention through improved muscle function. 2

Deficiency of this vitamin can lead to impaired bone mineralization and bone softening diseases including osteomalacia and osteoporosis in adults. Osteomalacia has significant risk factors for vertebral fractures, and spinal instrumentation failure. Low-energy fractures or fragility fractures have been found to be more common because of an increase in life expectancy 3. The total 25-hydroxyvitamin D (25-OH-VitD) level (the sum of 25-OH-vitamin D2 and 25-OH-vitamin D3) is the appropriate indicator of vitamin D body stores. Presently, there is no universal consensus about a treatment cut point. Studies suggest >30 ng/mL as the minimal concentration of 25-OH-Vit D Total is needed to avoid the adverse effects of deficiency4. Vitamin D insufficiency is considered at <30ng/ml to 21 ng/ml and Vitamin D Deficiency is <20 ng/ml of 25-OH-Vit D Total. Several researches have indicated increasing Vitamin D levels >45 ng/ml will increase their immune system, bone health, lower risks of neurological disorders and cancers. 3,4

Influential pathophysiological changes in osteoporosis include the hyperactivity of osteoclasts compared to the need for bone remodeling or a decreased activity of osteoblasts compared to the need for bone cavity repair or laying down new bone.5 Osteoporosis has become synonymous with decreased bone mineral density (BMD). Bone Marrow Density scans (DXA) allows accurate diagnosis of osteoporosis, estimation of fracture risk, and monitoring of patients undergoing treatment.5 In postmenopausal women and men age 50 years and older, the WHO diagnostic T-score criteria categorizes a normal DXA scan of <1.0 or above, low bone mass or osteopenia has a T score between <1.0 and -2.5, and osteoporosis is designated with a T-score at -2.5 or below) are applied to BMD measurement by central DXA at the lumbar spine and femoral neck. 5

This study was done in two parts. Part 1 was the Retrospective Study from November 1, 2012 to October 31, 2014 and Part 2 is the Prospective pilot from July 1, 2015-June 30, 2016. We are anticipating to raise the awareness and identify the importance of evaluating for hypovitaminosis D and bone marrow density preoperatively in Neurosurgery Clinic for 12 months. Our goal is to show treating bone health in spinal diseased patients preoperatively will provide optimal bone health with better long term outcomes requiring less revision surgeries for our patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 years old or older.
  • Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014.

排除标准

  • Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery.
  • (Part 2, Observational Study)
  • (Screening period July 1, 2015-June 30, 2016)
  • Inclusion Criteria:
  • 50 years old or older.
  • Serum Vitamin D level checked prior to or at surgery.
  • BMD exam performed anytime within 2 years prior to surgery.
  • Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31,
  • Exclusion Criteria:
  • Subjects diagnosed with:
  • Chronic Renal Disease with a GFR < 45 at Stage IV
  • Metastatic Spinal Disease
  • Bariatric surgery
  • Seizure medication
  • Chronic steroid use greater than 3 months at time of surgery.

结局指标

主要结局

(Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level

时间窗: Pre-op and at 3, 6, 12 months post-op

1. Vitamin D values. We will categorize it to different levels: if the value is \<30 ng/ml to 21 ng/ml-then it is insufficient; if the value is \<20 ng/ml, then it is deficient.

(Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level

时间窗: Within 30 days (pre-op)

Prospective Vitamin D lab of 25 Hydroxyvitamin D Total \<30 ng/ml in the population \>50 years old will have increased incidence of progressive spinal disease.

(Part 2, Prospective Study) Bone Marrow Density Results (DMD, DEXA)

时间窗: Within 2 years prior to spinal surgery

Categorized as normal, osteopenia, and osteoporosis

次要结局

  • (Part 2) Demographics(Screening)
  • (Part 1) Demographics(Screening)
  • (Part 1) Medical History(Screening - immediately post-op)
  • (Part 2 ) Medical History(Screening - 12 months post-op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jana Reed

Jana Reed, APN

OSF Healthcare System

研究点 (1)

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