Pelvic FractureNCT00594906
Use of Teriparatide to Accelerate Fracture Healing
A study testing Teriparatide in people with Pelvic Fracture, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2012
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females must be menopausal (no menses within the last 12 months)
- Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum
- Maximum of 2 weeks post fracture
- Mental status consistent with completing the study protocol
Who cannot join
- Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds
- Received radiation treatment to any site at any time in the past
- Received chemotherapy for cancer at any time in the past
- Any active cancer
- Surgical repair (or attempted repair) of the fracture site in the pelvis
- Use of any bone-active medications
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- Use of anticonvulsant therapy
- Use of immunosuppressants
- Any renal, gastrointestinal, liver, or metabolic bone disease
- Pregnancy
- High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.
Read the detailed description
Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.
This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.
- Conditions
- Pelvic Fracture
- Being tested
- Teriparatide, Placebo
- Keywords
- Fracture Healing, Teriparatide, Forteo, Pelvic Fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
PlaceboDrug
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Injection | Active comparator | 30 participants will receive teriparatide (Forteo) injection pens. Receives: Drug: Teriparatide |
| Placebo | Placebo comparator | 30 participants will receive placebo injection pens. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of a Fracture From a Low Energy Fall
Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)
Measured: Measured at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: The study was terminated due to poor enrollment.
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 Pelvic FractureStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Edward Puzas, University of Rochester
- Investigators
- J.Edward Puzas, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594906
- Sponsor's protocol ID
- P50AR054041
- Other IDs
- P50AR054041
- Status last verified
- Mar 2013
- First submitted
- 7 Jan 2008
- Last updated
- 19 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Teriparatide to Accelerate Fracture Healing
- ClinicalTrials.gov ID
- NCT00594906
- Acronym / sponsor ID
- P50AR054041
- Conditions
- Pelvic Fracture
- Keywords
- Fracture Healing, Teriparatide, Forteo, Pelvic Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to poor enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Study start
- Jan 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 24 Apr 2013
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 compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.
Detailed description
Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.
This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection | Active comparator | Drug: Teriparatide30 participants will receive teriparatide (Forteo) injection pens. |
| Placebo | Placebo comparator | Drug: Placebo30 participants will receive placebo injection pens. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females must be menopausal (no menses within the last 12 months)
- Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum
- Maximum of 2 weeks post fracture
- Mental status consistent with completing the study protocol
Key exclusion criteria (11 listed)
- Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds
- Received radiation treatment to any site at any time in the past
- Received chemotherapy for cancer at any time in the past
- Any active cancer
- Surgical repair (or attempted repair) of the fracture site in the pelvis
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: ForteoDaily 20-mcg subcutaneous injections for the duration of the study (16 weeks) | Drug | Injection |
| PlaceboDaily 20-mcg subcutaneous injections for the duration of the study (16 weeks) | Drug | Placebo |
Primary outcome
Healing of a Fracture From a Low Energy Fall
Time frame: Measured at 16 weeks
Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
- 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.
J.Edward Puzas, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teriparatide in people with Pelvic Fracture, run by University of Rochester 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Dec 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 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?
Healing of a Fracture From a Low Energy Fall (time frame: Measured at 16 weeks). 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 19 Dec 2014.