Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.
The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
20 ug daily over 12 months
10 min/day for 12 months
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Edward Hines, Jr, VA Hospital
Maywood, Illinois, United States
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
The mean change in BMD of the total hip after 12 month of treatment
Time frame: Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
The mean change in BMD at the lumbar spine from baseline after 12 month of treatment
Time frame: Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
The mean change in BMD of the femoral neck after 12 month of treatment
Time frame: Baseline to 12 Months
C-terminal Telopeptide
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Time frame: Baseline to 12 Months
Bone-specific Alkaline Phosphatase
The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Time frame: Baseline to 12 Months
Amino-terminal Propeptide of Type 1 Collagen
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Time frame: Baseline to 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.