Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

Prior treatment

• History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);
• Drugs geared toward increasing BMD longer than a six month duration after SCI;
• As determined by study staff review of my medications, prescribed moderate or high dose corticosteroids (\>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI; and

Other illness

• Active and/or history of coronary heart disease or stroke;
• Bone cancer;
• As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year
• Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;
• Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);
• Heterotopic ossification (HO) of the distal femur (the knee end of the thigh bone). HO is a condition where bone tissue forms outside of the skeleton. If HO is found in any other area than the distal femur it will not prevent my participation in the study.;
• History of chronic alcohol abuse;
• Current diagnosis of cancer or history of cancer;

Lab values

• Diagnosis of hypercalcemia (high levels of calcium in the blood);
• As determined by study staff review of my medications a bisphosphonate for heterotopic ossification (HO), or other medications to treat osteoporosis other than calcium and vitamin D;

Other

• Long-bone fracture of the leg within the past year;
• Postmenopausal women;
• Men with known low functioning tests before SCI;
• Pregnancy;
• Life expectancy less than 5 years.

• Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C);
• Duration of SCI less than 6 months;
• Males and females (premenopausal) between the ages of 18 and 55 years old; and a safe range of BMD right above the knee as determined by study staff review;