The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI). This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.
This extension study will enroll individuals who have completed treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Weekly oral alendronate 70 mg for 12 months
Daily oral 1000 mg Calcium
Daily oral 1000 IU
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
BMD of Total Hip by DXA
The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
Time frame: 12 months
C-terminal Telopeptide (CTX)
The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.
Time frame: 12 months
BMD by DXA at the Lumbar Spine
The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
Time frame: 12 months
Amino-terminal Propeptide of Type 1 Collagen (P1NP)
The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.
Time frame: 12 months
Bone-specific Alkaline Phosphatase (BSAP)
The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.
Time frame: 12 months
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