Spinal Cord InjuryPhase 2NCT02025179
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
A Phase 2 study testing Teriparatide and Vibration in people with Spinal Cord Injury and Bone Loss, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment. 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 14 Aug 2015
- 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
- Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury".
- Adherence rate for teriparatide use of ≥60%.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Individuals who could not tolerate teriparatide treatment.
- Individuals who will not be able to return for all study visits.
- Patients may not be receiving any other investigational agents.
- Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: 12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI
The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment.
This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.
Read the detailed description
This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent study to be treated for a second year and will allow those individuals who received teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy. This study will determine if two years of exposure to teriparatide will result in a greater increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects will be evaluated at 6 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
- Keywords
- Teriparatide, Osteoporosis, Spinal Cord Injury, Bone Diseases, Metabolic Bone Diseases, Musculoskeletal Diseases, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Nervous System, Wounds and Injuries, Bone Density Conservation Agents, Physiological Effects of Drugs, Pharmacologic Actions, Vibration
- Medical subject headings
- Spinal Cord Injuries, Bone Diseases, Metabolic, Osteoporosis, Bone Diseases, Musculoskeletal Diseases, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
Teriparatide 20 ug daily Sub-Q over 12 months
VibrationDevice
Also called Soloflex Whole Body Vibration platform
Vibration 10 min/day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide and vibration | Experimental | Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months 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 Dual-energy X-ray Absorptiometry (DXA)
The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Measured: Baseline to 24 months
Secondary outcomes (5)
C-terminal Telopeptide
The mean percent change in C-terminal telopeptide from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Measured: Baseline to 24 Months
Bone Mineral Density (BMD) by DXA at the Lumbar Spine
The mean percent change in BMD at the lumbar spine from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Measured: Baseline to 24 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
The mean percent change in BMD of the femoral neck after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Measured: Baseline to 24 Months
Amino-terminal Propeptide of Type 1 Collagen
The mean percent change in Amino-terminal of type 1 collagen from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Measured: Baseline to 24 Months
Bone-specific Alkaline Phosphatase
The mean percent change in Bone-specific alkaline phosphatase from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
Measured: Baseline to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2013
- Primary completion14 Aug 2015
- Study completion14 Aug 2015
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.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025179
- Sponsor's protocol ID
- A1195
- Status last verified
- Aug 2018
- First submitted
- 21 Dec 2013
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI
- ClinicalTrials.gov ID
- NCT02025179
- Acronym / sponsor ID
- A1195
- Conditions
- Spinal Cord Injury, Bone Loss, Osteoporosis
- Keywords
- Teriparatide, Osteoporosis, Spinal Cord Injury, Bone Diseases, Metabolic Bone Diseases, Musculoskeletal Diseases, Spinal Cord Diseases, Central Nervous System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2013 (actual)
- Primary completion
- 14 Aug 2015 (actual)
- Study completion
- 14 Aug 2015 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment.
This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.
Detailed description
This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent study to be treated for a second year and will allow those individuals who received teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy. This study will determine if two years of exposure to teriparatide will result in a greater increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects will be evaluated at 6 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teriparatide and vibration | Experimental | Drug: Teriparatide, Device: VibrationExperimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury".
- Adherence rate for teriparatide use of ≥60%.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (4 listed)
- Individuals who could not tolerate teriparatide treatment.
- Individuals who will not be able to return for all study visits.
- Patients may not be receiving any other investigational agents.
- Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
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: ForteoTeriparatide 20 ug daily Sub-Q over 12 months | Drug | Teriparatide and vibration |
| VibrationAlso: Soloflex Whole Body Vibration platformVibration 10 min/day for 12 months | Device | Teriparatide and vibration |
Primary outcome
Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)
Time frame: Baseline to 24 months
The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).
5 secondary outcomes
C-terminal Telopeptide
Time frame: Baseline to 24 Months
Bone Mineral Density (BMD) by DXA at the Lumbar Spine
Time frame: Baseline to 24 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
Time frame: Baseline to 24 Months
Amino-terminal Propeptide of Type 1 Collagen
Time frame: Baseline to 24 Months
Bone-specific Alkaline Phosphatase
Time frame: Baseline to 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Schnitzer, MD, PhD principal investigator
Northwestern University
1 site 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 Northwestern University at 1 site 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 7 inclusion and 4 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 25 Sep 2018). 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 Dual-energy X-ray Absorptiometry (DXA) (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.