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

NCT ID: NCT00826228

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Osteoporosis; Bone Loss; Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTH/Weight-Bearing

Group Type: EXPERIMENTAL

teriparatide

Intervention Type: DRUG

teriparatide 20ug daily sc for 6 months

weight-bearing

Intervention Type: OTHER

device assisted walking

Interventions

teriparatide

teriparatide 20ug daily sc for 6 months

Intervention Type: DRUG

weight-bearing

device assisted walking

Intervention Type: OTHER

Other Intervention Names

Forteo; exercise

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

Thomas J. Schnitzer

OTHER

Sponsor Role: lead

Responsible Party

Thomas J. Schnitzer

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas J Schnitzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00003009

Identifier Type: -

Identifier Source: org_study_id