Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jan 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for osteoporosis, a condition where bones become weak, in individuals who have had a spinal cord injury (SCI) for over three years. The treatment involves two medications: romosozumab, which aims to help build bone density, and denosumab, which is used afterward to help maintain or continue increasing bone density. Participants will receive romosozumab for 12 months, followed by denosumab for another 12 months. The trial is designed to see if this combination can improve bone health in people with chronic SCI.

To be eligible for the trial, participants must be between 18 and 65 years old, have a motor-complete or incomplete spinal cord injury, and have a specific low bone density measurement. There are certain health conditions and medications that could exclude someone from participating, such as recent fractures, heart disease, or other serious illnesses. The study is currently active but not recruiting new participants at this time. If someone qualifies, they can expect to be monitored closely throughout the trial to assess how well the treatment is working and to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Motor-complete or incomplete SCI \[all levels of lesion\] classified using International Standards for Neurological Classification for Spinal Cord Injury (ISNCSCI) impairment scale\] as ISNCSCI score A-C
• • Duration of injury \>3 years
• • Males (18-65 years old) and females (premenopausal, between the ages of 18 and 55 years old).
• • aBMD at the distal femur \<1.0 g/cm2 (determined at screening)
• Exclusion Criteria:
• • Long-bone fracture of the leg within the past year
• • History of prior bone disease (Paget's hyperparathyroidism, etc.)
• • Active and/or history of coronary heart disease or stroke within the past year
• • Postmenopausal women
• • Men with known hypogonadism prior to SCI
• • Anabolic therapy longer than six months duration after SCI
• • Glucocorticoid administration longer than three months duration within the last year, and/or 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
• • Endocrinopathies (hyperthyroidism, Cushing's disease or syndrome, etc.)
• • Severe underlying chronic disease (e.g., COPD, end-stage heart disease, chronic renal failure)
• • Heterotopic ossification (HO) of the knee region (the distal femoral epiphysis is the primary endpoint); HO to any other boney region will not prevent study participation as long as contraindicated medications have not been prescribed)
• • Chronic alcohol abuse
• • Hypocalcemia
• • Pregnancy
• • Prescribed a bisphosphonate for HO, or prescribed any other agent to treat osteoporosis other than calcium and vitamin D
• • Electrical stimulation of the lower extremities
• • Current diagnosis of cancer or history of cancer
• • Osteosarcoma
• • Life expectancy less than 5 years