Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Condition: Spinal Cord Injury; Bone Loss; Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Intervention: Teriparatide; vibration
Intervention description: 20 ug daily over 12 months; 10 min/day for 12 months
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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