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

Completed · Phase 2

Conditions studied: Spinal Cord Injury, Bone Loss, Osteoporosis

In brief

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.

Key facts

Study ID

NCT01225055

Run by

Thomas J. Schnitzer

People needed

60

Starts

2010-10-01

Expected to finish

2016-08-01

Last updated by the study team

2025-12-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Edward Hines, Jr, VA Hospital — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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