Phase 4 N=12 Treatment

Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)

Osteoporosis · Bone Loss · Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00826228 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: BMD at Left Total Hip — 0.02 % change in BMD (gm/cm2) from baseline

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: teriparatide (Drug); weight-bearing (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Thomas J. Schnitzer
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY BMD at Left Total Hip	0.02	—
SECONDARY P1NP	61.4	—

Summary

Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.

Eligibility Criteria

Inclusion Criteria

Age 18-75 years
Complete SCI - total loss of motor function below level of lesion
Capable of positioning to have DEXA performed
Capable of undertaking the weight-bearing exercise regime
Capable of reading and understanding informed consent document
Able to self-administer PTH or have someone in the family who can do so
T score 2x normal
For males, significantly abnormal free testosterone levels
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.
No previous history of bisphosphonate use
No previous use of other bone-specific agents during past 2 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00826228). 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.