Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

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.

Age

21–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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

Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

What this study is about

Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

What this study is about