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

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ClinicalTrials.gov Identifier: NCT01225055
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : June 22, 2017
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Edward Hines Jr. VA Hospital
University of Illinois at Chicago
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Bone Loss Osteoporosis Drug: Teriparatide Device: vibration Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Study Start Date : October 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Teriparatide with vibration applied in conjuction
 Drug: Teriparatide
20 ug daily over 12 months
Other Name: Forteo

Device: vibration
10 min/day for 12 months


Outcome Measures
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Primary Outcome Measures :
  1. Bone Mineral Density BMD of the Total Hip as Assessed by DXA. [ Time Frame: Baseline to 12 Months ]
    The mean change in BMD of the total hip after 12 month of treatment


Secondary Outcome Measures :
  1. Bone Mineral Density (BMD) by DXA at the Lumbar Spine. [ Time Frame: Baseline to 12 Months ]
    The mean change in BMD at the lumbar spine from baseline after 12 month of treatment

  2. Bone Mineral Density (BMD) by DXA at Femoral Neck [ Time Frame: Baseline to 12 Months ]
    The mean change in BMD of the femoral neck after 12 month of treatment

  3. C-terminal Telopeptide [ Time Frame: Baseline to 12 Months ]
    The mean change in C-terminal telopeptide from baseline after 12 month of treatment

  4. Bone-specific Alkaline Phosphatase [ Time Frame: Baseline to 12 Months ]
    The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy

  5. Amino-terminal Propeptide of Type 1 Collagen [ Time Frame: Baseline to 12 Months ]
    The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225055


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Edward Hines, Jr, VA Hospital
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Thomas J. Schnitzer
Edward Hines Jr. VA Hospital
University of Illinois at Chicago
Investigators
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Principal Investigator: Thomas J Schnizter, MD, PhD Northwestern University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01225055    
Other Study ID Numbers: STU00033380
First Posted: October 20, 2010    Key Record Dates
Results First Posted: June 22, 2017
Last Update Posted: June 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoporosis
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents