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

This study is currently recruiting participants.

Verified by Northwestern University, June 2009

First Received: January 20, 2009 Last Updated: June 17, 2009 History of Changes

Sponsors and Collaborators:	Northwestern University Eli Lilly and Company Rehabilitation Institute of Chicago
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00826228

Purpose

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	Intervention	Phase
Osteoporosis Bone Loss Spinal Cord Injury	Drug: teriparatide Other: weight-bearing	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis Spinal Cord Injuries

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

BMD at distal femur/proximal tibia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bone markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PTH/Weight-Bearing: Experimental	Drug: teriparatide teriparatide 20ug daily sc for 6 months Other: weight-bearing device assisted walking

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826228

Contacts

Contact: Lisa Maskala-Streff

312-238-2816

lstreff@ric.org

Locations

United States, Illinois
Rehabilitation Institute of Chicago	Recruiting
Chicago, Illinois, United States, 60611
Contact: Lisa Maskala-Streff 312-238-2816 lstreff@ric.org
Principal Investigator: Thomas J Schnitzer, MD, PhD

Sponsors and Collaborators

Northwestern University

Eli Lilly and Company

Rehabilitation Institute of Chicago

Investigators

Principal Investigator:

Thomas J Schnitzer, MD, PhD

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University Feinberg School of Medicine ( Thomas J Schnitzer/Principal Investigator )
Study ID Numbers:	STU00003009
Study First Received:	January 20, 2009
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00826228 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Spinal Cord Diseases
Teriparatide
Wounds and Injuries
Osteoporosis
Central Nervous System Diseases
Disorders of Environmental Origin
Bone Density Conservation Agents

Bone Diseases, Metabolic
Trauma, Nervous System
Bone Diseases
Hormones
Body Weight
Spinal Cord Injuries
Musculoskeletal Diseases

Additional relevant MeSH terms:

Spinal Cord Diseases
Teriparatide
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Osteoporosis
Central Nervous System Diseases
Disorders of Environmental Origin

Bone Diseases, Metabolic
Bone Density Conservation Agents
Trauma, Nervous System
Bone Diseases
Pharmacologic Actions
Spinal Cord Injuries
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 11, 2009