At a glance
ClinicalIndex Comparison Record- ✓Age ≥21 years
- ✓Taking average ≥5 mg/day prednisone or equivalent for ≥3 months prior to screening
- ✕Bisphosphonate use within past 6 months
- ✕Estradiol or equivalent >30 micrograms/day in past 3 months
- ✕History of alcoholism or drug abuse in past year
- ✕Pregnancy or nursing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Teriparatide, Alendronate Sodium, and 1 other intervention for Osteoporosis. Completed, enrolled 428 participants across 15 sites in 6 countries.
Detailed Summary
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
Study Details
Timeline
Interventions
20 micrograms/day, injection, 36 months
10 mg/day, oral, 36 months
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months