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

Primary Purpose

Spinal Cord Injury, Bone Loss, Osteoporosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Teriparatide
vibration
Sponsored by
Thomas J. Schnitzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of Medicine
  • Edward Hines, Jr, VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Teriparatide

Vibration

Teriparatide and vibration

Arm Description

Teriparatide alone with sham vibration

Vibration alone with placebo-teriparatide

Teriparatide with vibration applied in conjuction

Outcomes

Primary Outcome Measures

Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
The mean change in BMD of the total hip after 12 month of treatment

Secondary Outcome Measures

Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
The mean change in BMD at the lumbar spine from baseline after 12 month of treatment
Bone Mineral Density (BMD) by DXA at Femoral Neck
The mean change in BMD of the femoral neck after 12 month of treatment
C-terminal Telopeptide
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Bone-specific Alkaline Phosphatase
The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Amino-terminal Propeptide of Type 1 Collagen
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment

Full Information

First Posted
October 19, 2010
Last Updated
May 30, 2018
Sponsor
Thomas J. Schnitzer
Collaborators
Edward Hines Jr. VA Hospital, University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01225055
Brief Title
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Official Title
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas J. Schnitzer
Collaborators
Edward Hines Jr. VA Hospital, University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Bone Loss, Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide
Arm Type
Experimental
Arm Description
Teriparatide alone with sham vibration
Arm Title
Vibration
Arm Type
Experimental
Arm Description
Vibration alone with placebo-teriparatide
Arm Title
Teriparatide and vibration
Arm Type
Experimental
Arm Description
Teriparatide with vibration applied in conjuction
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
20 ug daily over 12 months
Intervention Type
Device
Intervention Name(s)
vibration
Intervention Description
10 min/day for 12 months
Primary Outcome Measure Information:
Title
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
Description
The mean change in BMD of the total hip after 12 month of treatment
Time Frame
Baseline to 12 Months
Secondary Outcome Measure Information:
Title
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
Description
The mean change in BMD at the lumbar spine from baseline after 12 month of treatment
Time Frame
Baseline to 12 Months
Title
Bone Mineral Density (BMD) by DXA at Femoral Neck
Description
The mean change in BMD of the femoral neck after 12 month of treatment
Time Frame
Baseline to 12 Months
Title
C-terminal Telopeptide
Description
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Time Frame
Baseline to 12 Months
Title
Bone-specific Alkaline Phosphatase
Description
The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Time Frame
Baseline to 12 Months
Title
Amino-terminal Propeptide of Type 1 Collagen
Description
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Time Frame
Baseline to 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Schnizter, MD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Edward Hines, Jr, VA Hospital
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30334093
Citation
Haider IT, Lobos SM, Simonian N, Schnitzer TJ, Edwards WB. Bone fragility after spinal cord injury: reductions in stiffness and bone mineral at the distal femur and proximal tibia as a function of time. Osteoporos Int. 2018 Dec;29(12):2703-2715. doi: 10.1007/s00198-018-4733-0. Epub 2018 Oct 17.
Results Reference
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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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