Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24 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. |
Drug: Romosozumab
Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month
Other Names:
Drug: Denosumab
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
Other Names:
|
| Active Comparator: Denosumab Baseline to Month 24 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. |
Drug: Denosumab
Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Bone mineral density (BMD) of the distal femur metaphysis [Baseline to 24 months]
BMD at the distal femur metaphysis will be obtained by dual energy X-ray absorptiometry (DXA)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Traumatic motor-complete SCI C4-L2 (AIS grade A & B);
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Duration of SCI less than 6 months;
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Males and females (premenopausal) between the ages of 18 and 50 years old; and a safe range of BMD right above the knee as determined by study staff review;
Exclusion Criteria:
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Active and/or history of coronary heart disease or stroke;
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Bone cancer;
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Long-bone fracture of the leg within the past year;
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History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);
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Postmenopausal women;
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Men with known low functioning tests before SCI;
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Drugs geared toward increasing BMD longer than a six month duration after SCI;
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As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year
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Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;
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Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);
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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.;
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History of chronic alcohol abuse;
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Diagnosis of hypercalcemia (high levels of calcium in the blood);
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Pregnancy;
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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;
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Current diagnosis of cancer or history of cancer;
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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
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Life expectancy less than 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kessler Institute for Rehabilitation | West Orange | New Jersey | United States | 07052 |
| 2 | James J. Peters VA Medical Center | Bronx | New York | United States | 10468 |
Sponsors and Collaborators
- James J. Peters Veterans Affairs Medical Center
- Kessler Institute for Rehabilitation
Investigators
- Principal Investigator: Steven C Kirshblum, M.D., Kessler Institute for Rehabilitation
Study Documents (Full-Text)
None provided.More Information
Publications
- Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.
- Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.
- McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, Bolognese MA, Goemaere S, Bone HG, Zanchetta JR, Maddox J, Bray S, Grauer A. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 Aug;33(8):1397-1406. doi: 10.1002/jbmr.3452. Epub 2018 May 22.
- BAU-19-22