Spinal Cord InjuryPhase 2NCT01225055
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
A Phase 2 study testing Teriparatide and vibration in people with Spinal Cord Injury and Bone Loss, run by Thomas J. Schnitzer at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spinal Cord Injury, Bone Loss, Osteoporosis
- What is being tested?
- Teriparatide and vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Edward Hines, Jr, VA Hospital
Maywood, Illinois, 60153
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Bone Loss, Osteoporosis
- Being tested
- Teriparatide, vibration
- Medical subject headings
- Spinal Cord Injuries, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
20 ug daily over 12 months
vibrationDevice
10 min/day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Experimental | Teriparatide alone with sham vibration Receives: Drug: Teriparatide |
| Vibration | Experimental | Vibration alone with placebo-teriparatide Receives: Device: vibration |
| Teriparatide and vibration | Experimental | Teriparatide with vibration applied in conjuction Receives: Drug: Teriparatide; Device: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12 Months
Secondary outcomes (5)
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
Measured: Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
The mean change in BMD of the femoral neck after 12 month of treatment
Measured: Baseline to 12 Months
C-terminal Telopeptide
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Measured: Baseline to 12 Months
Bone-specific Alkaline Phosphatase
The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Measured: Baseline to 12 Months
Amino-terminal Propeptide of Type 1 Collagen
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas J. Schnitzer
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Hines Jr. VA Hospital, University of Illinois Chicago, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor-investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnizter, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225055
- Sponsor's protocol ID
- STU00033380
- Other IDs
- CDMRP-SC090010
- Status last verified
- Nov 2025
- First submitted
- 19 Oct 2010
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30334093
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01225055
- Acronym / sponsor ID
- STU00033380
- Conditions
- Spinal Cord Injury, Bone Loss, Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thomas J. SchnitzerUniversity, hospital or other
- Collaborators
- Edward Hines Jr. VA Hospital, University of Illinois Chicago, Congressionally Directed Medical Research Programs
- Study start
- Oct 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 22 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Experimental | Drug: TeriparatideTeriparatide alone with sham vibration |
| Vibration | Experimental | Device: vibrationVibration alone with placebo-teriparatide |
| Teriparatide and vibration | Experimental | Drug: Teriparatide, Device: vibrationTeriparatide with vibration applied in conjuction |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: Forteo20 ug daily over 12 months | Drug | Teriparatide, Teriparatide and vibration |
| vibration10 min/day for 12 months | Device | Teriparatide and vibration, Vibration |
Primary outcome
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
5 secondary outcomes
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
Time frame: Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
Time frame: Baseline to 12 Months
C-terminal Telopeptide
Time frame: Baseline to 12 Months
Bone-specific Alkaline Phosphatase
Time frame: Baseline to 12 Months
Amino-terminal Propeptide of Type 1 Collagen
Time frame: Baseline to 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30334093Haider 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Schnizter, MD, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriparatide and vibration in people with Spinal Cord Injury and Bone Loss, run by Thomas J. Schnitzer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density BMD of the Total Hip as Assessed by DXA. (time frame: Baseline to 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.