Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chron… (NCT01225055) | Clinical Trial Compass
CompletedPhase 2
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
United States60 participantsStarted 2010-10
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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 protoc…
What they're measuring
1
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.