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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00223769
Eligibility Criteria:
Inclusion Criteria:
Part-A
* Diagnosed with a traumatic injury to spinal cord
* Motor complete injury at level of C5 to T12
* Date of injury at least one year prior to enrollment
* Sufficient upper body strength to participate in a 12-week resistance training program with accommodation for disability in hand strength and/or grasping
* Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan
* Willingness to take study medication for 12 weeks twice a day by mouth
Part-B:
* Diagnosed with a traumatic injury to the spinal cord
* Motor incomplete injury at any level
* Date of injury at least one year prior to enrollment
* Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan
* Ability to stand independently with or without the aid of assistive device(s)
* Willingness to take study medication for 12 weeks twice a day by mouth
Exclusion Criteria:
Active medical problems including:
* Uncontrolled diabetes
* Cardiovascular disease
* Cancer
* Liver disease
* Hypocalcaemia
* Nephritic syndrome
* HIV/AIDS
* Pressure ulcers of grade 3 or 4
* Shoulder pathology
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT00223769
Study Brief:
Protocol Section:
NCT00223769