Overview

This trial is active, not recruiting.

Conditions spinal cord injury, bone loss, osteoporosis
Treatments teriparatide, vibration
Phase phase 2
Sponsor Thomas J. Schnitzer
Collaborator Edward Hines Jr. VA Hospital
Start date October 2010
End date August 2015
Trial size 60 participants
Trial identifier NCT01225055, STU00033380

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Teriparatide alone with sham vibration
teriparatide Forteo
20 ug daily over 12 months
(Experimental)
Vibration alone with placebo-teriparatide
vibration
10 min/day for 12 months
(Experimental)
Teriparatide with vibration applied in conjuction
teriparatide Forteo
20 ug daily over 12 months
vibration
10 min/day for 12 months

Primary Outcomes

Measure
BMD determined by DXA at the distal femur
time frame: 0, 3, 6, 9, and 12 months

Secondary Outcomes

Measure
BMD at other skeletal locations
time frame: 0, 3, 6, 9, and 12 monthgs
Bone microstructure parameters
time frame: 0, 3, 6, 9, and 12 months
bone markers
time frame: 0, 3, 6, 9, and 12 months

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Principal investigator Thomas J Schnizter, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Northwestern University.