Arthritis Clinical Trials

I. Introduction:

While generalized osteoporosis causes tremendous disability in patients with RA and occurs relatively frequently in such patients, there has been little research on treatments for osteoporosis in patients with RA. Not only are there important questions about the effects of teriparatide on BMD in patients with RA, but little is known about how it might affect localized bone erosions or RA disease activity.

Recent data in a mouse model of RA suggest that intermittent PTH in the setting of potent immunosuppressives may indeed heal bone erosions. This study showed an additive effect of PTH in addition to a TNF antagonist on erosion healing. To the best of our knowledge, this has yet to be demonstrated in humans. That is the primary aim of the proposed study.

II. Objectives and Hypotheses:

To assess the effects of teriparatide among a group of patients with RA and erosions, all using TNF antagonists, with respect to:

1. Joint erosion volume by 3D CT scan;
2. Lumbar BMD by DXA;
3. Hip BMD by DXA; and
4. RA disease activity measured by the Disease Activity Score (DAS) and acute phase reactants.

The hypotheses to be tested include:

1. Joint erosion scores, measured by 3D CT scan, will be significantly improved at study completion in patients taking teriparatide.
2. Teriparatide will significantly increase BMD at all sites as measured by DXA.
3. RA disease activity measures will be stable during the study year.