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

Primary Purpose

Osteoporosis, Bone Loss, Spinal Cord Injury

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

teriparatide

weight-bearing

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTH/Weight-Bearing

Arm Description

Outcomes

Primary Outcome Measures

BMD at Left Total Hip

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

Secondary Outcome Measures

P1NP

amino-terminal propeptide of type I collagen (P1NP)

Full Information

NCT ID

NCT00826228

First Posted

January 20, 2009

Last Updated

June 3, 2013

Sponsor

Thomas J. Schnitzer

Collaborators

Eli Lilly and Company, Shirley Ryan AbilityLab

1. Study Identification

Unique Protocol Identification Number

NCT00826228

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas J. Schnitzer

Collaborators

Eli Lilly and Company, Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Bone Loss, Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTH/Weight-Bearing

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

teriparatide

Other Intervention Name(s)

Forteo

Intervention Description

teriparatide 20ug daily sc for 6 months

Intervention Type

Other

Intervention Name(s)

weight-bearing

Other Intervention Name(s)

exercise

Intervention Description

device assisted walking

Primary Outcome Measure Information:

Title

BMD at Left Total Hip

Description

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

Time Frame

Baseline to 6 months

Secondary Outcome Measure Information:

Title

P1NP

Description

amino-terminal propeptide of type I collagen (P1NP)

Time Frame

Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas J Schnitzer, MD, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rehabilitation Institute of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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