Clinical trial NCT02534714: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovitaminosis D
Spinal Disease
Osteoporosis
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
Collaborators: name: University of Illinois College of Medicine at Peoria
First posted: 2015-08-28
Enrollment: 460
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (Part 1, Retrospective Study) - patients diagnosed with any form of spinal disease who underwent spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from November 1, 2012 to October 31, 2014 who had a serum vitamin D level collected as standard of care prior to surgery.

(Part 2, Prospective Study) - patients diagnosed with any form of spinal disease that underwent cervical, thoracic, and/or lumbar spinal fusion at OSF/INI by Dr. Daniel Fassett, MD, MBA, Neurosurgeon from July 1, 2015 to June 30, 2016 who had a serum vitamin D level and bone marrow density scan collected as standard of care prior to surgery.

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

Detailed description: 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.

Research Question:

Part 1 - Retrospective Study

1. What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?

Part 2- Prospective Study (screening period July 1, 2015-June 30, 2016)

1. What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
2. Do patients with Hypovitaminosis D maintain therapeutic levels between 45 ng/ml to 75 ng/ml in approximately 3, 6, and 12 months postoperatively with supplements of Vitamin D3?
3. What are the incidences of osteopenia and osteoporosis in elective spinal fusion patients based on a Dexascans in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon?
4. Do the patients' demographic information, such as age, sex, BMI, and family history influence the outcome measures (Vitamin D deficiency, Osteopenia, and Osteoporosis)?

Eligibility criteria: (Part 1, Retrospective Study)

Inclusion Criteria:

1. 50 years old or older.
2. 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.

   Exclusion Criteria:
3. 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:

1. 50 years old or older.
2. Serum Vitamin D level checked prior to or at surgery.
3. BMD exam performed anytime within 2 years prior to surgery.
4. 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, 2016.

   Exclusion Criteria:
5. 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.

Primary outcomes:
measure: (Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level
timeFrame: Within 30 days (pre-op)
measure: (Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level
timeFrame: Pre-op and at 3, 6, 12 months post-op
measure: (Part 2, Prospective Study) Bone Marrow Density Results (DMD, DEXA)
timeFrame: Within 2 years prior to spinal surgery
Secondary outcomes:
measure: (Part 1) Demographics
timeFrame: Screening
measure: (Part 1) Medical History
timeFrame: Screening - immediately post-op
measure: (Part 2) Demographics
timeFrame: Screening
measure: (Part 2 ) Medical History
timeFrame: Screening - 12 months post-op
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: OSF Saint Francis, Illinois Neurological Institute
name: Todd McCall, MD
role: STUDY_CHAIR
affiliation: OSF Saint Francis Medical Center, Illinois Neurological Institute
name: Jana Reed, APN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.
citation: Kim TH, Yoon JY, Lee BH, Jung HS, Park MS, Park JO, Moon ES, Kim HS, Lee HM, Moon SH. Changes in vitamin D status after surgery in female patients with lumbar spinal stenosis and its clinical significance. Spine (Phila Pa 1976). 2012 Oct 1;37(21):E1326-30. doi: 10.1097/BRS.0b013e318268ff05.
citation: Dipaola CP, Bible JE, Biswas D, Dipaola M, Grauer JN, Rechtine GR. Survey of spine surgeons on attitudes regarding osteoporosis and osteomalacia screening and treatment for fractures, fusion surgery, and pseudoarthrosis. Spine J. 2009 Jul;9(7):537-44. doi: 10.1016/j.spinee.2009.02.005. Epub 2009 Mar 28.
citation: Heaney RP. Vitamin D: how much do we need, and how much is too much? Osteoporos Int. 2000;11(7):553-5. doi: 10.1007/s001980070074. No abstract available.
citation: Manolagas SC. Birth and death of bone cells: basic regulatory mechanisms and implications for the pathogenesis and treatment of osteoporosis. Endocr Rev. 2000 Apr;21(2):115-37. doi: 10.1210/edrv.21.2.0395.
citation: Blake GM, Fogelman I. The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Postgrad Med J. 2007 Aug;83(982):509-17. doi: 10.1136/pgmj.2007.057505.