Osteoporosis Clinical Trial
Official title:
Treatment With Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
The objective of the proposed work is to determine whether administration for 12 months of romosozumab (evenity) followed by 12 months of denosumab (prolia) will maintain bone mass at the knee in subjects with chronic SCI.
The purpose of this study is to address the gap in the treatment of osteoporosis in individuals with chronic SCI by partially restoring BMD with romosozumab treatment for 12 months and then to maintain, or further increase, BMD with denosumab treatment for 12 months. A two group, randomized, double-blind, placebo-controlled clinical trial will be conducted in 39 participants who have chronic (> 3 years), motor-complete or incomplete SCI and areal BMD (aBMD) values at the distal femur of at the distal femur ≥0.6 g/cm2 but ≤1.0 g/cm2 measured by dual photon X-ray absorptiometry (DXA). The intervention group will receive 12 months of romosozumab followed by 12 months of denosumab, and the control group will receive 12 months of placebo followed by 12 months denosumab ;
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