Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
2 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 19, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
June 22, 2017
CompletedDecember 2, 2025
November 1, 2025
4.8 years
October 19, 2010
May 30, 2017
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline to 12 Months
Secondary Outcomes (5)
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
Baseline to 12 Months
C-terminal Telopeptide
Baseline to 12 Months
Bone-specific Alkaline Phosphatase
Baseline to 12 Months
Amino-terminal Propeptide of Type 1 Collagen
Baseline to 12 Months
Study Arms (3)
Teriparatide
EXPERIMENTALTeriparatide alone with sham vibration
Vibration
EXPERIMENTALVibration alone with placebo-teriparatide
Teriparatide and vibration
EXPERIMENTALTeriparatide with vibration applied in conjuction
Interventions
20 ug daily over 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas J. Schnitzerlead
- Edward Hines Jr. VA Hospitalcollaborator
- University of Illinois at Chicagocollaborator
- Congressionally Directed Medical Research Programcollaborator
Study Sites (2)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Edward Hines, Jr, VA Hospital
Maywood, Illinois, 60153, United States
Related Publications (1)
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.
PMID: 30334093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Thomas Schnitzer
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J Schnizter, MD, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 19, 2010
First Posted
October 20, 2010
Study Start
October 1, 2010
Primary Completion
August 1, 2015
Study Completion
August 1, 2016
Last Updated
December 2, 2025
Results First Posted
June 22, 2017
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share