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

• Sponsor: Thomas J. Schnitzer (Other)
• Overall Status: Completed
• CT.gov ID: NCT00826228
• Collaborator: Eli Lilly and Company (Industry), Shirley Ryan AbilityLab (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Bone Loss; Spinal Cord Injury	Drug: teriparatide; Other: weight-bearing	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. BMD at Left Total Hip [Baseline to 6 months]

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

Secondary Outcome Measures

1. P1NP [Baseline to 6 months]

   amino-terminal propeptide of type I collagen (P1NP)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Thomas J. Schnitzer
• Eli Lilly and Company
• Shirley Ryan AbilityLab

Investigators

• Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT00826228
• Other Study ID Numbers: STU00003009
• First Posted: Jan 22, 2009
• Last Update Posted: Jul 11, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries; Teriparatide

Study Results

Participant Flow

Recruitment Details	Recruitment from outpatient clinic at rehab hospital

Arm/Group Title	PTH/Weight-Bearing
Arm/Group Description	PTH 20ug/day plus assisted weight-bearing on a Lokomat
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	PTH/Weight-Bearing
Arm/Group Description	PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.0 (7.8)
Sex: Female, Male (Count of Participants)
Female	2 16.7%
Male	10 83.3%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PTH/Weight-Bearing
Arm/Group Description	PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
Measure Participants	11
Mean (Standard Deviation) [% change in BMD (gm/cm2) from baseline]	0.02 (2.21)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Only 8 of the total 12 participants enrolled had serum available for testing

Arm/Group Title	PTH/Weight-Bearing
Arm/Group Description
Measure Participants	8
Mean (Standard Deviation) [% change from baseline]	61.4 (99.3)

Adverse Events

Arm/Group Title	PTH/Weight-Bearing
Arm/Group Description	PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
All Cause Mortality
	PTH/Weight-Bearing
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PTH/Weight-Bearing
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	PTH/Weight-Bearing
	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)
Musculoskeletal and connective tissue disorders
fracture	1/12 (8.3%)	1

Limitations/Caveats

Small numbers of subjects analyzed with considerable between-subject variability.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.