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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2027
  • participants needed
    40
  • sponsor
    James J. Peters Veterans Affairs Medical Center
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Updated on 29 October 2021
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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.

Description


Details
Condition Osteoporosis, Spinal Cord Injuries
Age 18years - 50years
Treatment Romosozumab, Denosumab
Clinical Study IdentifierNCT05101018
SponsorJames J. Peters Veterans Affairs Medical Center
Last Modified on29 October 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Traumatic motor-complete SCI C4-L2 (AIS grade A & B)
Duration of SCI less than 6 months
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

Active and/or history of coronary heart disease or stroke
Bone cancer
Long-bone fracture of the leg within the past year
History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.)
Postmenopausal women
Men with known low functioning tests before SCI
Drugs geared toward increasing BMD longer than a six month duration after SCI
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
Diagnosis of hypercalcemia (high levels of calcium in the blood)
Pregnancy
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
Current diagnosis of cancer or history of cancer
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
Life expectancy less than 5 years
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