Clinical Trials Directory

Trials / Completed

CompletedNCT00941473

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Henry Ford Health System · Academic / Other
Sex
Female
Age
55 Years – 80 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGTriamcinilone (kenalog)Epidural steroid injection of 80mg of Triamcinilone.

Timeline

Start date
2007-07-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2009-07-17
Last updated
2024-02-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00941473. Inclusion in this directory is not an endorsement.