An interventional study of Teriparatide and Placebo in Pelvic Fracture, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-12-19.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 10 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 participants will receive teriparatide (Forteo) injection pens.
Drug: Teriparatide
30 participants will receive placebo injection pens.
Drug: Placebo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Also known as: Forteo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
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
| Milestone | Forteo Injection | Placebo Injection |
|---|---|---|
| Started | 7 | 3 |
| Completed | 6 | 1 |
| Not completed | 1 | 2 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Death | 0 | 1 |
Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)
| participants | Placebo Patients | Forteo Patients |
|---|---|---|
| Healed | 0 | 1 |
| Healing | 1 | 4 |
| Did not compelte CT scan | 2 | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Forteo Injection | — | 0/7 (0%) | 1/7 (14.3%) |
| Placebo Injection | — | 0/3 (0%) | 0/3 (0%) |
| Event | Forteo Injection | Placebo Injection |
|---|---|---|
| FallGeneral disorders | 1/7 | 0/3 |
| Age, Categorical(Participants) | Injection | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 5 | 2 | 7 |
| Age, Continuous(years) | Injection | Placebo | Total |
|---|---|---|---|
| Mean | 78 ± 14 | 66 ± 5 | 75 ± 13 |
| Sex: Female, Male(Participants) | Injection | Placebo | Total |
|---|---|---|---|
| Female | 7 | 3 | 10 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Injection | Placebo | Total |
|---|---|---|---|
| United States | 7 | 3 | 10 |
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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