At a glance
ClinicalIndex Comparison Record- ✓Age >18 years
- ✓Prior glucocorticoid exposure: prednisone ≥7.5mg/day for ≥6 months
- ✓Currently on prednisone ≥5mg/day
- ✓Low bone density: DXA T score ≤-1.5 at lumbar spine (L1-L4), total hip, or femoral neck, with or without prevalent vertebral fracture
- ✕Other generalized bone diseases (hyperparathyroidism, hypoparathyroidism, Paget's disease)
- ✕Diseases affecting bone metabolism: alcoholism, hyperthyroidism, renal impairment (creatinine >2.5mg/dL), hepatic impairment (SGOT >2x upper limit of normal)
- ✕Urinary calcium excretion >400mg/day
- ✕History of drug abuse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis?
In Brief
A Phase 4 clinical trial evaluating Risedronate and Parathyroid Hormone for Osteoporosis. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
Study Details
Timeline
Interventions
One 35mg tab of risedronate/placebo taken once a week for one year.
This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.