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

NCT02534714 | Completed

• 1 other identifier: 632002
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypovitaminosis D; Spinal Disease; Osteoporosis

Outcome Measures

Primary Outcomes (3)

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

  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.

  Within 30 days (pre-op)

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

  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.

  Pre-op and at 3, 6, 12 months post-op

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

  Categorized as normal, osteopenia, and osteoporosis

  Within 2 years prior to spinal surgery

Secondary Outcomes (4)

• (Part 1) Demographics

  Screening

• (Part 1) Medical History

  Screening - immediately post-op

• (Part 2) Demographics

  Screening

• (Part 2 ) Medical History

  Screening - 12 months post-op

Study Arms (2)

Retrospective (Part 1) Group

This is a retrospective pilot study in 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. Only spinal fusion patients with a serum Vitamin D level prior to or at time of surgery and after surgery are included in this review. The following variables will be utilized to characterize the sample: age, sex, ethnicity, BMI, smoking history, pre-op Vitamin D level and supplement given. The charts reviewed will belong to subjects who were closely followed at the OSF/INI clinic.

Prospective (Part 2) Group

This is a prospective pilot study in subjects 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. (Screening period July 1, 2015-June 30, 2016) Only spinal fusion patients with a serum Vitamin D level, and Bone Marrow Density prior to or at time of surgery are included in this study. The following variables will be utilized to characterize the sample: age, sex, ethnicity, BMI, smoking history, pre-op Vitamin D level and supplement given. The subjects were closely followed at the OSF/INI clinic post-operatively at 3, 6, and 12 months. Pre-op Vitamin D level and Bone Marrow Density will be measured at the baseline, and again at 3, 6, and 12 months.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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, 2016.
• 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.

Sponsors & Collaborators

• OSF Healthcare System: lead
• University of Illinois College of Medicine at Peoria: collaborator

Study Sites (1)

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Related Publications (6)

• 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.

  PMID: 20926724 BACKGROUND

• 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.

  PMID: 22805343 BACKGROUND

• 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.

  PMID: 19328744 BACKGROUND

• 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.

  PMID: 11069187 BACKGROUND

• 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.

  PMID: 10782361 BACKGROUND

• 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.

  PMID: 17675543 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Spinal Diseases; Osteoporosis

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Metabolic; Metabolic Diseases

Study Officials

• Todd McCall, MD

  OSF Saint Francis, Illinois Neurological Institute

  STUDY CHAIR

• Jana Reed, APN

  OSF Saint Francis Medical Center, Illinois Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jana Reed, APN

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

US (1)