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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

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ClinicalTrials.gov Identifier: NCT02534714
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : August 31, 2015
Sponsor:
Collaborator:
University of Illinois College of Medicine at Peoria
Information provided by (Responsible Party):
Jana Reed, OSF Healthcare System

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

Condition or disease
Hypovitaminosis D Spinal Disease Osteoporosis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 580 participants
Observational Model: Cohort
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 Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2018


Group/Cohort
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.




Primary Outcome Measures :
  1. (Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level [ Time Frame: 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.

  2. (Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level [ Time Frame: 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.

  3. (Part 2, Prospective Study) Bone Marrow Density Results (DMD, DEXA) [ Time Frame: Within 2 years prior to spinal surgery ]
    Categorized as normal, osteopenia, and osteoporosis


Secondary Outcome Measures :
  1. (Part 1) Demographics [ Time Frame: Screening ]
    Gender, Age, Ethnicity

  2. (Part 1) Medical History [ Time Frame: Screening - immediately post-op ]
    Medical History, BMI, smoking status, supplementation

  3. (Part 2) Demographics [ Time Frame: Screening ]
    Gender, Age, Ethnicity

  4. (Part 2 ) Medical History [ Time Frame: Screening - 12 months post-op ]
    Family history osteoporosis, smoking status, calcium and vitamin D supplementation, and diabetes



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534714


Contacts
Contact: Kimberly L Cooley, RN 309-655-4727 kimberly.l.cooley@osfhealthcare.org
Contact: Christine S. Brown 309-655-3448 christine.s.brown@osfhealthcare.org

Locations
United States, Illinois
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Kimberly L Hartwig, RN    309-655-4229    kimberly.hartwig@osfhealthcare.org   
Contact: Stephanie Madrigal, BS    309-655-7871    stephanie.g.madrigal@osfhealthcare.org   
Principal Investigator: Jana Reed, APN         
Sub-Investigator: Daniel Fassett, MD         
Sponsors and Collaborators
OSF Healthcare System
University of Illinois College of Medicine at Peoria
Investigators
Study Chair: Todd McCall, MD OSF Saint Francis, Illinois Neurological Institute
Principal Investigator: Jana Reed, APN OSF Saint Francis Medical Center, Illinois Neurological Institute

Publications:
Responsible Party: Jana Reed, Jana Reed, APN, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT02534714     History of Changes
Other Study ID Numbers: 632002
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Rickets
Osteoporosis
Bone Diseases, Metabolic
Avitaminosis
Vitamin D Deficiency
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Metabolism Disorders