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Bone as Regulator of Energy Balance and Male Fertility after SCI: A Pilot Study (Osteocalcin Protocol)

Recruiting

This study proposes a cross-sectional case-control pilot study. Spinal Cord Injury (SCI) is associated with altered bone metabolism, male infertility, and increased rates of insulin resistance. The researchers will perform testing for 30 men with SCI and 10 without SCI. Data will be used to power subsequent clinical trials. A Fairview letter of support has also been uploaded.

I'm interested

18 Years and over
This study is also accepting healthy volunteers
Inclusion Criteria:
SCI
Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study -Male age 18-50 -Have completed inpatient rehabilitation and are living in the community -Have motor complete SCI Use a wheelchair as primary mobility mode -English and non-English speakers No SCI
Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study -Male age 18-50 -Able to ambulate independently -English and non-English speakers
Exclusion Criteria:
SCI
Exclusion Criteria:
-presence of other neurological condition -use of chronic ventilator support -metabolic bone disease -thyroid disorder -current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year). -Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. No SCI
Exclusion Criteria:
-presence of neurological condition -metabolic bone disease -thyroid disorder -current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year). -known history of or found on baseline testing to have osteoporosis. -known history of or found on baseline testing to have diabetes. -known history of or found on baseline testing to have infertility. -Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Spinal Cord Injury

Leslie Morse - morsel@umn.edu
Leslie Morse
Pilot
STUDY00011054
PMR-2020-29213

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