Phase 2 N=61 Randomized Triple-blind Treatment

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

Spinal Cord Injury · Bone Loss · Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT01225055 ↗

Enrolled (actual)

Serious AEs

26.7%

Results posted

Jun 2017

Primary outcome: Primary: Bone Mineral Density BMD of the Total Hip as Assessed by DXA. — 0.66; 0.63; 0.64; 0.65 g/cm^2 — p=0.84

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Teriparatide (Drug); vibration (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Thomas J. Schnitzer
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Bone Mineral Density BMD of the Total Hip as Assessed by DXA.	0.66; 0.63; 0.64; 0.65; 0.63; 0.65	0.84
SECONDARY Bone Mineral Density (BMD) by DXA at the Lumbar Spine.	1.04; 1.00; 1.02; 1.05; 1.01; 1.04	0.64
SECONDARY Bone Mineral Density (BMD) by DXA at Femoral Neck	0.66; 0.63; 0.62; 0.66; 0.64; 0.63	0.72
SECONDARY C-terminal Telopeptide	0.38; 0.31; 0.38; 0.72; 0.25; 0.43	0.02 sig
SECONDARY Bone-specific Alkaline Phosphatase	15.3; 13.9; 12.4; 18.4; 11.6; 12.8	0.01 sig
SECONDARY Amino-terminal Propeptide of Type 1 Collagen	67.1; 64.7; 67.9; 128; 51.8; 90.1	0.00 sig

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 30ng/ml)
Normal calcium levels
Normal renal function (creatinine 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01225055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.