Pelvic Fracture
Conditions
Keywords
Fracture Healing, Teriparatide, Forteo, Pelvic Fractures
Brief summary
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.
Interventions
DRUGTeriparatide
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
DRUGPlacebo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of a Fracture From a Low Energy Fall | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Injection 30 participants will receive teriparatide (Forteo) injection pens.
Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) | 7 |
| Placebo 30 participants will receive placebo injection pens.
Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) | 3 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 5 | 78 years STANDARD_DEVIATION 14 | 75 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 3 participants | 7 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 0 / 3 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 |
Outcome results
Primary
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)
Time frame: Measured at 16 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Patients | Healing of a Fracture From a Low Energy Fall | Healed | 0 participants |
| Placebo Patients | Healing of a Fracture From a Low Energy Fall | Healing | 1 participants |
| Placebo Patients | Healing of a Fracture From a Low Energy Fall | Did not compelte CT scan | 2 participants |
| Forteo Patients | Healing of a Fracture From a Low Energy Fall | Healed | 1 participants |
| Forteo Patients | Healing of a Fracture From a Low Energy Fall | Healing | 4 participants |
| Forteo Patients | Healing of a Fracture From a Low Energy Fall | Did not compelte CT scan | 2 participants |