Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941473
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Shlomo Mandel, Henry Ford Health System

Brief Summary:

To evaluate for the effect of corticosteroid epidural injections on bone mineral density in postmenopausal women. Candidates for the study: Post menopausal women between the ages of 55 and 80. No history of bone disease. No thyroid/parathyroid disorder. not used injected or oral steroids in the last year. No recent smoking.

The purpose is to identify any significant change in bone mineral density with the use of epidural steroid injections. This may implicate the need for patient counseling regarding this possible side effect and the possible use of preventive measures to avoid this adverse effect.

Condition or disease Intervention/treatment Phase
To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid Inject To Assess the Changes in Bone Mineral Density. Drug: Triamcinilone (kenalog) Phase 4

Detailed Description:
Glucocorticoids reduce bone formation and increase bone loss via a variety of mechanisms. This effect has been shown to be dose-dependent. Doses as low as 10mg of Prednisone, has been shown to lower bone density over periods as short as 20 weeks, an effect which may be prevented with use of Calcium and Vitamin D. Inhaled Tramcinilone has also been shown to lead to dose-related loss of bone at the hip in premenopausal women. Clinic visits will be arranged for recruited patients at baseline and then at 3 and 6 months after the ESI and at any time for new-onset or severe back pain. During the initial visit, consent will be obtained, patient will be given details on the study design and rationale, severity and characteristics of back pain. Epidural corticosteroid injection (ESI) has been shown to decrease pain, speed return of function, and improve neurological signs in patients presenting with low back pain.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women
Study Start Date : July 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Epidural Steriod Injection
This study focuses on the changes in bone mineral density over time of the cohort previously described in the inclusion criteria (post-menopausal white women)
Drug: Triamcinilone (kenalog)
Epidural steroid injection of 80mg of Triamcinilone.

Primary Outcome Measures :
  1. Measurements will be taken at baseline and then repeated at 3,6, and 12 months after treatment. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Patients with low back pain and have consented to ESI. Age 55 and 5 years postmenopausal Caucasian women.

Exclusion Criteria:

  1. any women who doesn't meet the inclusion criteria
  2. Women with history of a disease affection bone turnover
  3. Women taking any drugs known to influence bone metabolism
  4. Women who had smoked within the preceding year
  5. Women with abnormal serum thyrotropin concentration, or high parathyroid hormone concentratons.
  6. Women who had received more than two short courses (lasting 2 weeks or less) of oral or parenteral glucocorticoids in the preceding year or any oral or pareneteral or local (intraarticular, paraspinal,...) or inhaled glucocorticoids in the preceding year
  7. Women diagnosed with osteoporosis (T score<=2.5) on baseline DXA or had history of osteoportic fracture.
  8. Pregnant women
  9. Severe scoliosis -

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 identifier (NCT number): NCT00941473

United States, Michigan
Henry Ford Hospital W. Bloomfield
West Bloomfield, Michigan, United States, 48322
Sponsors and Collaborators
Henry Ford Health System

Responsible Party: Shlomo Mandel, Shlomo Mandel, MD, Henry Ford Health System Identifier: NCT00941473     History of Changes
Other Study ID Numbers: J90067
patient care #80211089
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Shlomo Mandel, Henry Ford Health System:
Epidural Injection
Bone Density

Additional relevant MeSH terms:
Triamcinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors