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

NCT ID: NCT00941473

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Triamcinilone (kenalog)

Intervention Type: DRUG

Epidural steroid injection of 80mg of Triamcinilone.

Interventions

Triamcinilone (kenalog)

Epidural steroid injection of 80mg of Triamcinilone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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 -

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Charles S Day

Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Hospital W. Bloomfield

West Bloomfield, Michigan, United States

Countries

United States

Other Identifiers

IRB#4569

Identifier Type: -

Identifier Source: secondary_id

patient care #80211089

Identifier Type: -

Identifier Source: secondary_id

J90067

Identifier Type: -

Identifier Source: org_study_id