NCT00826228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 11, 2013

Completed
Last Updated

July 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

January 20, 2009

Results QC Date

April 17, 2013

Last Update Submit

June 3, 2013

Conditions

OsteoporosisBone LossSpinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • BMD at Left Total Hip

    Bone mineral density (gm/cm2) of the total hip region of interest on the left

    Baseline to 6 months

Secondary Outcomes (1)

  • P1NP

    Baseline to 6 months

Study Arms (1)

PTH/Weight-Bearing

EXPERIMENTAL
Drug: teriparatideOther: weight-bearing

Interventions

teriparatideDRUG

teriparatide 20ug daily sc for 6 months

Also known as: Forteo
PTH/Weight-Bearing
weight-bearingOTHER

device assisted walking

Also known as: exercise
PTH/Weight-Bearing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \<-2.5 or Z score \<-1.5 on evaluation of total hip BMD
  • No known endocrinopathies
  • Normal TSH levels
  • Normal 25-OH vitamin D levels
  • Normal calcium levels
  • Normal renal function (creatinine \<2.0mg/dl)
  • Able to return for all follow-up visits

You may not qualify if:

  • Surgical or other intervention resulting in metal or anatomy precluding obtaining DEXA and/or MRI measurements
  • Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
  • History of malignancy
  • History of radiation therapy
  • Unable to self-administer PTH or have it administered
  • Elevated liver function tests \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicSpinal Cord Injuries

Interventions

TeriparatideWeight-BearingExercise

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsMechanical PhenomenaPhysical PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Small numbers of subjects analyzed with considerable between-subject variability.

Results Point of Contact

Title
Thomas J Schnitzer
Organization
Northwestern University Feinberg School of Medicine
tjs@northwestern.edu
3125032315

Study Officials

  • Thomas J Schnitzer, MD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

July 11, 2013

Results First Posted

July 11, 2013

Record last verified: 2013-06

Locations

US(1)