Femur Neck Fracture
Conditions
Brief summary
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).
Detailed description
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: 1. A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture 2. A 6-month double-blind treatment period \[teriparatide 20 µg or placebo given once daily by SC injection\] 3. A 6-month observation period. 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.
Interventions
DRUGTeriparatide
Administered by SC injection
DRUGPlacebo
Administered by SC injection
DIETARY_SUPPLEMENTCalcium supplementation
Administered orally
DIETARY_SUPPLEMENTVitamin D supplementation
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced) * Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years * Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not performed as part of this study) * Have given written informed consent (participant or proxy) after being informed of the risks, medications, and study procedures
Exclusion criteria
* Increased baseline risk of osteosarcoma * History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis * Abnormally elevated serum calcium at screening * Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening * Severe vitamin D deficiency at screening * Active liver disease or jaundice * Significantly impaired renal function * Abnormal thyroid function not corrected by therapy * History of malignant neoplasm in the 5 years prior to screening * History of bone marrow or solid organ transplantation * History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to screening * Previous treatment with the following bone active drugs is allowed but must be discontinued at screening: oral bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. Androgen or other anabolic steroid use must be discontinued, except for use of physiologic replacement testosterone * Previous treatment with the following bone active drugs is exclusionary, if the stated treatment durations have been met: strontium ranelate for any duration, intravenous bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months preceding screening * Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation in any other clinical trial studying PTH, teriparatide, or other PTH analogs * Local or systemic treatment with bone morphogenic proteins or any other growth factor * Previous fracture(s) or bone surgery in the currently fractured hip * Soft-tissue infection at the operation site * Treatment with bone grafting or osteotomies * Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants, or with noninvasive interventions * Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head or pelvis; dislocations of the ankle, knee or hip
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pain Control During Ambulation | Up to 12 months | 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. Participants with an NRS score of \<7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores \>2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) \* 100. |
| Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | Up to 12 months | 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 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 \>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) \* 100. |
| Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | Up to 12 months | 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 \>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. |
| Percentage of Participants With Functional Evidence of Healing | 12 Months | 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. |
| Percentage of Participants Able to Ambulate | Up to 12 months | Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) \* 100. |
| Percentage of Participants Who Regain Their Prefracture Ambulatory Status | Up to 12 months | 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 analyzed) \* 100. |
| Percentage of Participants With Radiographic Evidence of Healing | Randomization up to 12 months | The signs of femoral neck fracture healing 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. |
| Mean Change From Baseline to 6 Months in Gait Speed | Baseline, up to 6 Months | 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 and adjusted for baseline, treatment group, region, fracture type, and fixation type. |
| Time to Revision Surgery | Baseline to revision surgery (up to 14.14 Months) | 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. |
| Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | Baseline, up to 6 Months | 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 mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction. |
| Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Baseline, up to 6 Months | WOMAC is: 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. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction. |
| Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score | Baseline, up to 6 Months | 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 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region. |
| Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | Baseline, 6 Months | 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) and adjusted for baseline, treatment group, region, fracture type, and fixation type. |
Countries
Australia, Canada, Denmark, Estonia, Finland, Hong Kong, India, Israel, Japan, Latvia, Lithuania, New Zealand, Norway, Puerto Rico, South Korea, Spain, Sweden, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. | 60 |
| Placebo Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. | 61 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Entry criteria not met | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 11 |
Baseline characteristics
| Characteristic | Teriparatide | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 68.49 years STANDARD_DEVIATION 11.321 | 69.73 years STANDARD_DEVIATION 11.698 | 70.96 years STANDARD_DEVIATION 12.023 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 53 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 34 Participants | 67 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 69 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 52 Participants | 27 Participants |
| Region of Enrollment Australia | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Canada | 3 participants | 4 participants | 1 participants |
| Region of Enrollment Denmark | 1 participants | 2 participants | 1 participants |
| Region of Enrollment India | 2 participants | 3 participants | 1 participants |
| Region of Enrollment Israel | 3 participants | 7 participants | 4 participants |
| Region of Enrollment Japan | 14 participants | 29 participants | 15 participants |
| Region of Enrollment Korea, Republic of | 9 participants | 18 participants | 9 participants |
| Region of Enrollment Latvia | 2 participants | 5 participants | 3 participants |
| Region of Enrollment Lithuania | 2 participants | 4 participants | 2 participants |
| Region of Enrollment New Zealand | 5 participants | 11 participants | 6 participants |
| Region of Enrollment Spain | 7 participants | 15 participants | 8 participants |
| Region of Enrollment Sweden | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Taiwan | 10 participants | 19 participants | 9 participants |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 43 Participants | 87 Participants | 44 Participants |
| Sex: Female, Male Male | 17 Participants | 34 Participants | 17 Participants |
| Surgical screw type Cancellous Screws | 54 participants | 107 participants | 53 participants |
| Surgical screw type Sliding Hip Screws | 6 participants | 14 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 61 | 31 / 60 | 18 / 53 | 16 / 49 |
| serious Total, serious adverse events | 6 / 61 | 2 / 60 | 6 / 53 | 2 / 49 |
Outcome results
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.
Time frame: 12 months
Population: Participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | 87 percentage of participants |
| Placebo | Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | 86 percentage of participants |
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 and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Time frame: Baseline, up to 6 Months
Population: Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Mean Change From Baseline to 6 Months in Gait Speed | -0.672 m/s | Standard Error 2.128 |
| Placebo | Mean Change From Baseline to 6 Months in Gait Speed | 1.524 m/s | Standard Error 2.018 |
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) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Time frame: Baseline, 6 Months
Population: Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | During ambulation (n = 45, 46) | 0.2 units on a scale | Standard Error 0.37 |
| Teriparatide | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | During 24 hours preceding visit (n = 47, 50) | -0.3 units on a scale | Standard Error 0.45 |
| Teriparatide | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | On weight bearing (n = 46, 49) | 0.7 units on a scale | Standard Error 0.39 |
| Placebo | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | During ambulation (n = 45, 46) | 0.2 units on a scale | Standard Error 0.36 |
| Placebo | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | During 24 hours preceding visit (n = 47, 50) | -0.8 units on a scale | Standard Error 0.42 |
| Placebo | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | On weight bearing (n = 46, 49) | 0.8 units on a scale | Standard Error 0.36 |
Secondary
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State 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 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
Time frame: Baseline, up to 6 Months
Population: All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score | 7.4 units on a scale | Standard Error 4.02 |
| Placebo | Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score | 7.6 units on a scale | Standard Error 3.87 |
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 mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Time frame: Baseline, up to 6 Months
Population: Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | PCS Month 6 (n = 49, 49) | -3.73 units on a scale | Standard Error 1.2 |
| Teriparatide | Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | MCS Month 6 (n = 49, 49) | -0.58 units on a scale | Standard Error 2.1 |
| Placebo | Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | PCS Month 6 (n = 49, 49) | -4.75 units on a scale | Standard Error 1.2 |
| Placebo | Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores | MCS Month 6 (n = 49, 49) | -0.49 units on a scale | Standard Error 2.1 |
Secondary
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
WOMAC is: 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. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Time frame: Baseline, up to 6 Months
Population: Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Physical Function Score - Month 6 (n=48, 51) | 12.9 units on a scale | Standard Error 4.36 |
| Teriparatide | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Pain Score - Month 6 ( n = 51, 51) | 8.2 units on a scale | Standard Error 3.76 |
| Teriparatide | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Stiffness Score - Month 6 (n = 51, 51) | 13.1 units on a scale | Standard Error 3.78 |
| Placebo | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Physical Function Score - Month 6 (n=48, 51) | 12.8 units on a scale | Standard Error 4.25 |
| Placebo | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Pain Score - Month 6 ( n = 51, 51) | 10.3 units on a scale | Standard Error 3.68 |
| Placebo | Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) | Stiffness Score - Month 6 (n = 51, 51) | 11.8 units on a scale | Standard Error 3.75 |
Secondary
Percentage of Participants Able to Ambulate
Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) \* 100.
Time frame: Up to 12 months
Population: Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants Able to Ambulate | 97.9 percentage of participants |
| Placebo | Percentage of Participants Able to Ambulate | 98 percentage of participants |
Secondary
Percentage of Participants Who Regain 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 analyzed) \* 100.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants Who Regain Their Prefracture Ambulatory Status | 73.2 percentage of participants |
| Placebo | Percentage of Participants Who Regain Their Prefracture Ambulatory Status | 56.9 percentage of participants |
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.
Time frame: 12 Months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants With Functional Evidence of Healing | 85.4 percentage of participants |
| Placebo | Percentage of Participants With Functional Evidence of Healing | 74.0 percentage of participants |
Secondary
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
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 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 \>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) \* 100.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | 88.0 percentage of participants |
| Placebo | Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | 82.4 percentage of participants |
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 \>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.
Time frame: Up to 12 months
Population: Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | 89.4 percentage of participants |
| Placebo | Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | 88.0 percentage of participants |
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. Participants with an NRS score of \<7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores \>2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) \* 100.
Time frame: Up to 12 months
Population: Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants With Pain Control During Ambulation | 91.5 percentage of participants |
| Placebo | Percentage of Participants With Pain Control During Ambulation | 89.8 percentage of participants |
Secondary
Percentage of Participants With Radiographic Evidence of Healing
The signs of femoral neck fracture healing 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.
Time frame: Randomization up to 12 months
Population: Participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Percentage of Participants With Radiographic Evidence of Healing | 78.3 percentage of participants |
| Placebo | Percentage of Participants With Radiographic Evidence of Healing | 78.7 percentage of participants |
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.
Time frame: Baseline to revision surgery (up to 14.14 Months)
Population: 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 = 51; placebo = 51.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Teriparatide | Time to Revision Surgery | 358.5 days |
| Placebo | Time to Revision Surgery | 350 days |