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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Bone Loss; Spinal Cord Injury
• Intervention / Treatment: Drug: teriparatide; Other: weight-bearing

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTH/Weight-Bearing	Drug: teriparatide; teriparatide 20ug daily sc for 6 months; Other Names: Forteo; Other: weight-bearing; device assisted walking; Other Names: exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
P1NP	amino-terminal propeptide of type I collagen (P1NP)	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Thomas J. Schnitzer
• Collaborators: Eli Lilly and Company; Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Bone Diseases; Bone Diseases, Metabolic; Wounds and Injuries; Osteoporosis; Spinal Cord Injuries; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: STU00003009