DRUG
Teriparatide
20 ug daily over 12 months
Status
Completed
Phase
Phase 2
Enrollment
60
Locations
2
Results
Posted
Publications
1
Study summary
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.
Interventions
DRUG
20 ug daily over 12 months
DEVICE
10 min/day for 12 months
Timeline
First posted
Oct 20, 2010
Study start
Oct 2010
Primary completion
Aug 2015
Study completion
Aug 2016
Results posted
Jun 22, 2017
Registry updated
Dec 2, 2025
Outcomes
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
Time frame · Baseline to 12 Months
The mean change in BMD of the total hip after 12 month of treatment
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
Time frame · Baseline to 12 Months
The mean change in BMD at the lumbar spine from baseline after 12 month of treatment
Bone Mineral Density (BMD) by DXA at Femoral Neck
Time frame · Baseline to 12 Months
The mean change in BMD of the femoral neck after 12 month of treatment
C-terminal Telopeptide
Time frame · Baseline to 12 Months
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Bone-specific Alkaline Phosphatase
Time frame · Baseline to 12 Months
The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Amino-terminal Propeptide of Type 1 Collagen
Time frame · Baseline to 12 Months
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Eligibility
Inclusion Criteria: Age \>21 years (must have closed epiphyses; PTH contraindicated if epiphyses open) * Both males and females * SCI with inability to ambulate independently * Capable of positioning to have DXA performed * Low bone mass at the total hip by DEXA (Z score \< 1.5; T score \< 2.5 or T score \<-2.0 plus preexisting fragility fracture) * Capable of reading and understanding informed consent document * Able to self-administer teriparatide or have someone in the family who can do so * No known endocrinopathies * Normal TSH levels * Normal 25-OH vitamin D levels (\> 30ng/ml) * Normal calcium levels * Normal renal function (creatinine \<2.0mg/dl) * Able to return for all follow-up visits Exclusion Criteria: Surgical or other intervention resulting in metal or anatomy precluding obtaining DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips). * Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients. * Have Paget's disease of the bone * Have unexplained high levels of f alkaline phosphatase in blood * Any active Gastrointestinal condition that results in malabsorption * History of presence of alcoholism or drug abuse within the 2 years prior to study screening * Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study * History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol. * History of radiation therapy * Unable to self-administer PTH or have it administered * Elevated liver function tests \>2x normal * Currently being prescribed anti-convulsants * Currently being prescribed glucocorticoids, other than inhaled glucocorticoids * Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication. * Previous history of PTH use * Pregnant, planning to become pregnant, or lactating
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Edward Hines, Jr, VA Hospital
Maywood, Illinois, United States
Publications
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Related PeptideStat pages
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