OsteoporosisPhase 4NCT00826228
Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)
A Phase 4 study testing teriparatide and weight-bearing in people with Osteoporosis and Bone Loss, run by Thomas J. Schnitzer at 1 site in United States.
Trial summary
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoporosis, Bone Loss, Spinal Cord Injury
- What is being tested?
- teriparatide and weight-bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2012
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Complete SCI - total loss of motor function below level of lesion
- Capable of positioning to have DEXA performed
- Capable of undertaking the weight-bearing exercise regime
- Capable of reading and understanding informed consent document
- Able to self-administer PTH or have someone in the family who can do so
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- T score <-2.5 or Z score <-1.5 on evaluation of total hip BMD
- No known endocrinopathies
- Normal TSH levels
- Normal 25-OH vitamin D levels
- 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 DEXA and/or MRI measurements
- Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
- History of malignancy
- History of radiation therapy
- Unable to self-administer PTH or have it administered
- Elevated liver function tests >2x normal
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- For males, significantly abnormal free testosterone levels
- 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.
- No previous history of bisphosphonate use
- No previous use of other bone-specific agents during past 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.
Read the detailed description
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.
- Conditions
- Osteoporosis, Bone Loss, Spinal Cord Injury
- Being tested
- teriparatide, weight-bearing
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teriparatideDrug
Also called Forteo
teriparatide 20ug daily sc for 6 months
weight-bearingOther
Also called exercise
device assisted walking
| Study group | Role | What they receive |
|---|---|---|
| PTH/Weight-Bearing | Experimental | Not described Receives: Drug: teriparatide; Other: weight-bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD at Left Total Hip
Bone mineral density (gm/cm2) of the total hip region of interest on the left
Measured: Baseline to 6 months
Secondary outcomes (1)
P1NP
amino-terminal propeptide of type I collagen (P1NP)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionDec 2012
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 OsteoporosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas J. Schnitzer
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Shirley Ryan AbilityLab
- Responsible party
- Sponsor-investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826228
- Sponsor's protocol ID
- STU00003009
- Status last verified
- Jun 2013
- First submitted
- 20 Jan 2009
- Last updated
- 11 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00826228
- Acronym / sponsor ID
- STU00003009
- Conditions
- Osteoporosis, Bone Loss, Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thomas J. SchnitzerUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Shirley Ryan AbilityLab
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Posted 11 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.
Detailed description
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTH/Weight-Bearing | Experimental | Drug: teriparatide, Other: weight-bearing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years
- Complete SCI - total loss of motor function below level of lesion
- Capable of positioning to have DEXA performed
- Capable of undertaking the weight-bearing exercise regime
- Capable of reading and understanding informed consent document
Key exclusion criteria (12 listed)
- Surgical or other intervention resulting in metal or anatomy precluding obtaining DEXA and/or MRI measurements
- Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
- History of malignancy
- History of radiation therapy
- Unable to self-administer PTH or have it administered
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 20ug daily sc for 6 months | Drug | PTH/Weight-Bearing |
| weight-bearingAlso: exercisedevice assisted walking | Other | PTH/Weight-Bearing |
Primary outcome
BMD at Left Total Hip
Time frame: Baseline to 6 months
Bone mineral density (gm/cm2) of the total hip region of interest on the left
1 secondary outcome
P1NP
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- 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 4 study testing teriparatide and weight-bearing in people with Osteoporosis and Bone Loss, run by Thomas J. Schnitzer 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 13 inclusion and 12 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 11 Jul 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 11 Jul 2013). 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?
BMD at Left Total Hip (time frame: Baseline to 6 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 11 Jul 2013.