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

James J. Peters Veterans Affairs Medical Center

Status and phase: Active, not recruiting; Phase 4

Conditions: Osteoporosis; Spinal Cord Injuries

Treatments: Drug: Denosumab; Drug: Romosozumab

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT05101018

BAU-19-60

Details and patient eligibility

About

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C);
2. Duration of SCI less than 6 months;
3. 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;

Exclusion criteria

1. Active and/or history of coronary heart disease or stroke;
2. Bone cancer;
3. Long-bone fracture of the leg within the past year;
4. History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);
5. Postmenopausal women;
6. Men with known low functioning tests before SCI;
7. Drugs geared toward increasing BMD longer than a six month duration after SCI;
8. As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year
9. Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;
10. Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);
11. 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.;
12. History of chronic alcohol abuse;
13. Diagnosis of hypercalcemia (high levels of calcium in the blood);
14. Pregnancy;
15. 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;
16. Current diagnosis of cancer or history of cancer;
17. 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
18. Life expectancy less than 5 years.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24

Experimental group

Description:

Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive romosozumab (210mg SQ) once a month for 12 months. After 12 months the same twenty (20) individuals will receive denosumab (60mg SQ) at month 12 and 18.

Treatment:

Drug: Romosozumab

Drug: Denosumab

Denosumab Baseline to Month 24

Active Comparator group

Description:

Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive denosumab (60 mg SQ) at baseline and 6, 12, and 18 months.

Treatment:

Drug: Denosumab