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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Eli Lilly and Company | INDUSTRY |
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This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.
Up to 24 postmenopausal women with osteoporosis who have been on bisphosphonate therapy for one year or more at any point prior to fracture and have sustained an atypical subtrochanteric or diaphyseal fracture will be enrolled. Subjects randomized to the two intervention arms will self-administer a daily SQ injection of the study medication for 12 months. The primary objective is to demonstrate greater radiologic evidence of healing at 10 weeks in patients on immediate teriparatide compared to those on delayed teriparatide who receive therapy six months after fracture. Secondary end points include (1) radiologic healing at 2, 6, 24, and 46 weeks; (2) increased bone density at 6 and 12 months as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, and femoral neck; (3) quality of life improvements at 10 weeks and 6 months as assessed by quality of life questionnaire and pain score; and (4) differences in biochemical markers of bone turnover in patient with upfront therapy compared to patients with delayed therapy and patients who refuse therapy or for whom teriparatide is contraindicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate teriparatide | Experimental | Open label teriparatide given immediately following surgical repair of fracture |
|
| Delayed teriparatide | Experimental | Open label teriparatide given six months following surgical repair of fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | 20 microgram once-daily subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic Evidence of Bone Healing | The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation. | 6, 12 months of treatment |
| Radiologic Evidence of Healing | Number of participants with persistence of alignment as determined by a radiologist. | at 10 weeks for immediate teriparatide group |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic Healing | at 2, 6, 24, and 48 weeks | |
| Increased Bone Density | Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan L. Greenspan, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, Osteoporosis Prevention & Treatment Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Teriparatide | Open label teriparatide given immediately following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection |
| FG001 | Delayed Teriparatide | Open label teriparatide given six months following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Teriparatide | Open label teriparatide given immediately following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection |
| BG001 | Delayed Teriparatide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Radiologic Evidence of Bone Healing | The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation. | Posted | Mean | Standard Error | units on a scale | 6, 12 months of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Teriparatide | Open label teriparatide given immediately following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elective back surgery | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Greenspan, MD | University of Pittsburgh | 412-692-2477 | greenspn@pitt.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| at 6 and 12 months |
| Quality of Life Improvements | Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life. | at 12 months |
| Difference in Biochemical Markers of Bone Turnover | upfront therapy group compared to delayed therapy group and no therapy group | intervals over 12-18 months depending on treatment group |
Open label teriparatide given six months following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Open label teriparatide given immediately following surgical repair of fracture
teriparatide: 20 microgram once-daily subcutaneous injection
| OG001 | Delayed Teriparatide | Open label teriparatide given six months following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection |
|
|
| Primary | Radiologic Evidence of Healing | Number of participants with persistence of alignment as determined by a radiologist. | Based on orthopedic surgeons' assessment, x-rays were not deemed necessary in over 30% of patients at week 10. Results presented are for those who had x-rays at 10 weeks to assess persistence of alignment for safety purposes. | Posted | Count of Participants | Participants | at 10 weeks for immediate teriparatide group |
|
|
|
| Secondary | Radiologic Healing | Data not collected at 2 and 6 weeks. Twenty-Four week (6 months) data is presented in 6 month outcomes, and 48 week (12 months) data as 12 month outcomes (See primary outcomes section above). | Posted | at 2, 6, 24, and 48 weeks |
|
|
| Secondary | Increased Bone Density | Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck | Posted | Mean | Standard Error | percentage change in BMD | at 6 and 12 months |
|
|
|
| Secondary | Quality of Life Improvements | Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life. | Posted | Mean | Standard Error | units on a scale | at 12 months |
|
|
|
| Secondary | Difference in Biochemical Markers of Bone Turnover | upfront therapy group compared to delayed therapy group and no therapy group | Funding unavailable for sample analysis. | Posted | intervals over 12-18 months depending on treatment group |
|
|
| 0 |
| 7 |
| 3 |
| 7 |
| 5 |
| 7 |
| EG001 | Delayed Teriparatide | Open label teriparatide given six months following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection | 0 | 6 | 2 | 6 | 5 | 6 |
| Ewings Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Discovered prior to initiation of treatment with teritparatide |
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| Cellulitis | Infections and infestations | Non-systematic Assessment | Developed cellulitis at surgical site following repair of femur fracture |
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| Abnormal coagulation profile | Blood and lymphatic system disorders | Systematic Assessment |
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| Hematoma | General disorders | Systematic Assessment | Hospitalized for incision and drainage of right hip hematoma at femoral surgical site |
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| aphasia | Nervous system disorders | Systematic Assessment |
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| myringotomy | Ear and labyrinth disorders | Systematic Assessment |
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| arthralgias | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment |
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| macular degeneration | Eye disorders | Systematic Assessment |
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| cataract removal | Surgical and medical procedures | Systematic Assessment |
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| deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| gingivitis | General disorders | Systematic Assessment |
|
| periodontal gum surgery | Surgical and medical procedures | Systematic Assessment |
|
| allergic rhinitis | Immune system disorders | Systematic Assessment |
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| coronary artery disease | Vascular disorders | Systematic Assessment |
|
| cardiac catheterization | Surgical and medical procedures | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
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| varicella zoster | Infections and infestations | Systematic Assessment |
|
| thigh pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Total Hip (6 months) |
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| Total Hip (12 months) |
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| Femoral Neck (6 months) |
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| Femoral Neck (12 months) |
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| Distal 1/3 Radius (6 months) |
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| Distal 1/3 Radius (12 months) |
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| Emotional health limitations |
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| Energy/Fatigue |
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| Emotional well-being |
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| Social functioning |
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| Pain |
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| General health |
|