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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Rehabilitation Institute of Chicago
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00826228
First received: January 20, 2009
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Bone Loss
Spinal Cord Injury
 Drug: teriparatide
Other: weight-bearing
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • BMD at distal femur/proximal tibia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH/Weight-Bearing Drug: teriparatide
teriparatide 20ug daily sc for 6 months
Other Name: Forteo
Other: weight-bearing
device assisted walking
Other Name: exercise

Detailed Description:

This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years
  2. Complete SCI - total loss of motor function below level of lesion
  3. Capable of positioning to have DEXA performed
  4. Capable of undertaking the weight-bearing exercise regime
  5. Capable of reading and understanding informed consent document
  6. Able to self-administer PTH or have someone in the family who can do so
  7. T score <-2.5 or Z score <-1.5 on evaluation of total hip BMD
  8. No known endocrinopathies
  9. Normal TSH levels
  10. Normal 25-OH vitamin D levels
  11. Normal calcium levels
  12. Normal renal function (creatinine <2.0mg/dl)
  13. Able to return for all follow-up visits

Exclusion Criteria:

  1. Surgical or other intervention resulting in metal or anatomy precluding obtaining DEXA and/or MRI measurements
  2. Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
  3. History of malignancy
  4. History of radiation therapy
  5. Unable to self-administer PTH or have it administered
  6. Elevated liver function tests >2x normal
  7. For males, significantly abnormal free testosterone levels
  8. Currently being prescribed anti-convulsants
  9. Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
  10. Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds.
  11. No previous history of bisphosphonate use
  12. No previous use of other bone-specific agents during past 2 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826228

Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Thomas J. Schnitzer
Eli Lilly and Company
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00826228     History of Changes
Other Study ID Numbers: STU00003009
Study First Received: January 20, 2009
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Spinal Cord Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013