Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50AR054041 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
The study was terminated due to poor enrollment.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection | Active Comparator | 30 participants will receive teriparatide (Forteo) injection pens. |
|
| Placebo | Placebo Comparator | 30 participants will receive placebo injection pens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 at 16 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J.Edward Puzas, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Forteo Injection | 30 participants will receive teriparatide (Forteo) injection pens. Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) |
| FG001 | Placebo Injection | 30 participants will receive placebo injection pens. Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Injection | 30 participants will receive teriparatide (Forteo) injection pens. Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | participants | Measured at 16 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Forteo Injection | Patients who randomized to the study drug, Forteo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment | Px hospitalized day after consent-fell on hip/head. Suffered 3rd cranial nerve infarction,discharged. Returned to ED complaining of both legs, increased confusion and UTI. Treated for all and discharged. Patient fell again, suffered head laceration. |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Edward Puzas | University of Rochester | (585) 275-3664 | edward_puzas@urmc.rochester.edu |
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) |
|
| Death |
|
30 participants will receive placebo injection pens.
Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Placebo Injection | Patients who were randomized to Placebo | 0 | 3 | 0 | 3 |
|
Not provided
Not provided
Not provided
| D007869 |
| Leg Injuries |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |