Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT04232657
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04232657
Study Brief:
Protocol Section:
NCT04232657