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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas J. Schnitzer
• Collaborators: Edward Hines Jr. VA Hospital; University of Illinois at Chicago
• Treatments: Teriparatide

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