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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826228
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Eli Lilly and Company
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. BMD at Left Total Hip [ Time Frame: Baseline to 6 months ]
    Bone mineral density (gm/cm2) of the total hip region of interest on the left

Secondary Outcome Measures :
  1. P1NP [ Time Frame: Baseline to 6 months ]
    amino-terminal propeptide of type I collagen (P1NP)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826228

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United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Thomas J. Schnitzer
Eli Lilly and Company
Shirley Ryan AbilityLab
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Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
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Responsible Party: Thomas J. Schnitzer, professor, Northwestern University Identifier: NCT00826228    
Other Study ID Numbers: STU00003009
First Posted: January 22, 2009    Key Record Dates
Results First Posted: July 11, 2013
Last Update Posted: July 11, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents