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Completed

NCT Number: NCT00826228

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Bone Loss Central Nervous System Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <-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

Exclusion criteria

  • 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

Treatment and study plan

Teriparatide

Drug

teriparatide 20ug daily sc for 6 months

Other names: Forteo

weight-bearing

Other

device assisted walking

Other names: exercise

Primary outcomes

  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 outcomes

  1. P1NP

    Time frame: Baseline to 6 months

    amino-terminal propeptide of type I collagen (P1NP)

Sponsors and collaborators

Lead sponsor

Thomas J. Schnitzer

Other

Collaborators

  • Eli Lilly and Company
  • Shirley Ryan AbilityLab

Registry information

Official study title

Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 22, 2009
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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