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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shlomo Mandel, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00941473
First received: July 16, 2009
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Measurements will be taken at baseline and then repeated at 3,6, and 12 months after treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941473

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

No publications provided

Responsible Party: Shlomo Mandel, Shlomo Mandel, MD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00941473     History of Changes
Other Study ID Numbers: J90067, IRB#4569, patient care #80211089
Study First Received: July 16, 2009
Last Updated: March 15, 2012
Health Authority: United States: Henry Ford Health System Collaborators

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

ClinicalTrials.gov processed this record on May 16, 2013