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

May 30, 2018 updated by: Thomas J. Schnitzer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Maywood, Illinois, United States, 60153
        • Edward Hines, Jr, VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teriparatide
Teriparatide alone with sham vibration
Drug: Teriparatide
20 ug daily over 12 months
Other Names:
  • 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 Names:
  • Forteo
Device: vibration
10 min/day for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 12 Months
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
Baseline to 12 Months
C-terminal Telopeptide
Time Frame: Baseline to 12 Months
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Baseline to 12 Months
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
Baseline to 12 Months
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
Baseline to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas J. Schnitzer

Collaborators

University of Illinois at Chicago
Edward Hines Jr. VA Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00033380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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