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Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

This study is currently recruiting participants.
Verified April 2013 by Northwestern University
Sponsor:
Collaborators:
Edward Hines Jr. VA Hospital
University of Illinois
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01225055
First received: October 19, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.


Condition Intervention Phase
Spinal Cord Injury
Bone Loss
Osteoporosis
 Drug: Teriparatide
Device: vibration
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • BMD determined by DXA at the distal femur [ Time Frame: 0, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMD at other skeletal locations [ Time Frame: 0, 3, 6, 9, and 12 monthgs ] [ Designated as safety issue: No ]
  • Bone microstructure parameters [ Time Frame: 0, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • bone markers [ Time Frame: 0, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriparatide
Teriparatide alone with sham vibration
 Drug: Teriparatide
20 ug daily over 12 months
Other Name: Forteo
Experimental: Vibration
Vibration alone with placebo-teriparatide
 Device: vibration
10 min/day for 12 months
Experimental: Teriparatide and vibration Drug: Teriparatide
20 ug daily over 12 months
Other Name: Forteo
Device: vibration
10 min/day for 12 months

Detailed Description:

The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age >21 years (must have closed epiphyses; PTH contraindicated if epiphyses open)

  • Both males and females
  • SCI with inability to ambulate independently
  • Capable of positioning to have DXA performed
  • Low bone mass at the total hip by DEXA (Z score < 1.5; T score < 2.5 or T score <-2.0 plus preexisting fragility fracture)
  • Capable of reading and understanding informed consent document
  • Able to self-administer teriparatide or have someone in the family who can do so
  • No known endocrinopathies
  • Normal TSH levels
  • Normal 25-OH vitamin D levels (> 30ng/ml)
  • 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 DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips).

  • Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients.
  • Have Paget's disease of the bone
  • Have unexplained high levels of f alkaline phosphatase in blood
  • Any active Gastrointestinal condition that results in malabsorption
  • History of presence of alcoholism or drug abuse within the 2 years prior to study screening
  • Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
  • History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol.
  • History of radiation therapy
  • Unable to self-administer PTH or have it administered
  • Elevated liver function tests >2x normal
  • 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. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication.
  • Previous history of PTH use
  • Pregnant, planning to become pregnant, or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225055

Contacts
Contact: Thomas Schnitzer, MD, PhD 3125032315 tjs@northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Thomas Schnitzer, MD, PhD     312-503-2315        
Edward Hines, Jr, VA Hospital Recruiting
Maywood, Illinois, United States
Contact: Rama Parachuri         rama.parachuri@va.gov    
Principal Investigator: Rama Parachuri, MD            
Sponsors and Collaborators
Thomas J. Schnitzer
Edward Hines Jr. VA Hospital
University of Illinois
Investigators
Principal Investigator: Thomas J Schnizter, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01225055     History of Changes
Other Study ID Numbers: STU00033380
Study First Received: October 19, 2010
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Spinal Cord Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013