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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-MC-GHDQ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).
This is a 12-month, Phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation. The study has 3 periods:
The primary objective is to assess the effect of 6 months of treatment with teriparatide 20 µg/day versus placebo on the proportion of men and postmenopausal women of at least 50 years of age with no revision surgery 12 months after internal fixation of a low-trauma femoral neck fracture.
All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Administered once daily by subcutaneous (SC) injection for 6 months |
|
| Teriparatide | Experimental | 20 microgram (µg) administered once daily by SC injection for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Administered by SC injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Radiographic Evidence of Healing | The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | 92103 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. |
| FG001 | Placebo | Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Administered by SC injection |
|
| Calcium supplementation | Dietary Supplement | Administered orally |
|
| Vitamin D supplementation | Dietary Supplement | Administered orally |
|
| Randomization up to 12 months |
| Percentage of Participants With Pain Control During Ambulation | The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100. | Up to 12 months |
| Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100. | Up to 12 months |
| Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100. | Up to 12 months |
| Percentage of Participants With Functional Evidence of Healing | Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100. | Up to 12 Months |
| Percentage of Participants Able to Ambulate | Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100. | Up to 12 months |
| Percentage of Participants Who Regained Their Prefracture Ambulatory Status | Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100. | Up to 12 months |
| Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type. | Baseline, 6 Months |
| Mean Change From Baseline to 6 Months in Gait Speed | The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type | Baseline, 6 Months |
| Time to Revision Surgery | Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact. | Baseline to Revision Surgery (up to 14.14 Months) |
| Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction. | Baseline, 6 Months |
| Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction. | Baseline, up to 6 Months |
| Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score | The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region. | Baseline, 6 Months |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Golden | Colorado | 80401 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Washington D.C. | District of Columbia | 20037 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gainesville | Georgia | 30501 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Morton Grove | Illinois | 60053 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46278 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Detroit | Michigan | 48202 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pittsburgh | Pennsylvania | 15212 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Charleston | South Carolina | 29425 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Johnson City | Tennessee | 37604 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Suwon | 442-721 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Basel | CH-4031 | Switzerland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lausanne | 1011 | Switzerland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ankara | 06010 | Turkey (Türkiye) |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Istanbul | 34755 | Turkey (Türkiye) |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Izmir | 35550 | Turkey (Türkiye) |
| Received at Least 1 Dose of Study Drug |
|
| Completed 6 Months |
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| Completed 12 Months |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set: All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. |
| BG001 | Placebo | Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Surgical screw type | Surgical screws used in initial surgery to repair femur neck hip fracture. | Number | participants |
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| 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 | Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure. | Participants who were randomized, received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of participants | 12 months |
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| Secondary | Percentage of Participants With Radiographic Evidence of Healing | The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100. | Participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Randomization up to 12 months |
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| Secondary | Percentage of Participants With Pain Control During Ambulation | The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100. | Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used. | Posted | Number | Percentage of participants | Up to 12 months |
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| Secondary | Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100. | Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours.. LOCF values used. | Posted | Number | Percentage of participants | Up to 12 months |
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| Secondary | Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100. | Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement. LOCF values used. | Posted | Number | Percentage of participants | Up to 12 months |
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| Secondary | Percentage of Participants With Functional Evidence of Healing | Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100. | Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used. | Posted | Number | Percentage of participants | Up to 12 Months |
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| Secondary | Percentage of Participants Able to Ambulate | Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100. | Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used | Posted | Number | Percentage of participants | Up to 12 months |
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| Secondary | Percentage of Participants Who Regained Their Prefracture Ambulatory Status | Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100. | Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used. | Posted | Number | Percentage of participants | Up to 12 months |
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| Secondary | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type. | Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement.. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, 6 Months |
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| Secondary | Mean Change From Baseline to 6 Months in Gait Speed | The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type | Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. | Posted | Least Squares Mean | Standard Error | m/s | Baseline, 6 Months |
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| Secondary | Time to Revision Surgery | Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact. | Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 14; placebo = 19. | Posted | Median | Full Range | Days | Baseline to Revision Surgery (up to 14.14 Months) |
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| Secondary | Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction. | Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, 6 Months |
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| Secondary | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction. | Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, up to 6 Months |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score | The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region. | Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, 6 Months |
|
Randomization to Study Completion
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 | Placebo | Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. | 2 | 20 | 5 | 20 | ||
| EG001 | Teriparatide | Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. | 1 | 18 | 3 | 18 | ||
| EG002 | Placebo Follow-up | Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. | 3 | 15 | 4 | 15 | ||
| EG003 | Teriparatide Follow-up | Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. | 1 | 12 | 3 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Multiple system atrophy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bladder catheterisation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Removal of internal fixation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Wrist surgery | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg 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 |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Hungary |
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| Belgium |
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| Romania |
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| Netherlands |
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| Korea, Republic of |
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| Sliding Hip Screws |
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