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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826228
• Other study ID #: STU00003009
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2009
• Last updated: June 3, 2013
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss
• Osteoporosis
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• teriparatide
teriparatide 20ug daily sc for 6 months

Other:
• weight-bearing
device assisted walking

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Thomas J. Schnitzer	Eli Lilly and Company, Rehabilitation Institute of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD at Left Total Hip	Bone mineral density (gm/cm2) of the total hip region of interest on the left	Baseline to 6 months	No
Secondary	P1NP	amino-terminal propeptide of type I collagen (P1NP)	Baseline to 6 months	No