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

Thomas J. Schnitzer

Status and phase: Completed; Phase 2

Conditions: Osteoporosis; Spinal Cord Injury; Bone Loss

Treatments: Device: vibration; Drug: Teriparatide

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01225055

STU00033380

CDMRP-SC090010 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Teriparatide

Experimental group

Description:

Teriparatide alone with sham vibration

Treatment:

Drug: Teriparatide

Vibration

Experimental group

Description:

Vibration alone with placebo-teriparatide

Treatment:

Device: vibration

Teriparatide and vibration

Experimental group

Description:

Teriparatide with vibration applied in conjuction

Treatment:

Drug: Teriparatide

Device: vibration