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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01473589
Registration number
NCT01473589
Ethics application status
Date submitted
14/11/2011
Date registered
17/11/2011
Date last updated
16/04/2015
Titles & IDs
Public title
Effect of Teriparatide on Hip Fracture Healing
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Scientific title
Effect of Teriparatide on Femoral Neck Fracture Healing
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Secondary ID [1]
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B3D-MC-GHDN
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Secondary ID [2]
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13467
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Femur Neck Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Teriparatide
Treatment: Drugs - Placebo
Other interventions - Calcium supplementation
Other interventions - Vitamin D supplementation
Placebo Comparator: Placebo - Administered once daily by subcutaneous (SC) injection for 6 months
Experimental: Teriparatide - 20 microgram (µg) administered once daily by SC injection for 6 months
Treatment: Drugs: Teriparatide
Administered by SC injection
Treatment: Drugs: Placebo
Administered by SC injection
Other interventions: Calcium supplementation
Administered orally
Other interventions: Vitamin D supplementation
Administered orally
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Percentage of Participants With Radiographic Evidence of Healing
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization up to 12 months
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Secondary outcome [2]
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Percentage of Participants With Pain Control During Ambulation
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 12 months
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Secondary outcome [3]
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Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 12 months
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Secondary outcome [4]
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Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 12 months
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Secondary outcome [5]
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Percentage of Participants With Functional Evidence of Healing
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Assessment method [5]
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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.
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Timepoint [5]
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12 Months
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Secondary outcome [6]
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Percentage of Participants Able to Ambulate
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 12 months
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Secondary outcome [7]
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Percentage of Participants Who Regain Their Prefracture Ambulatory Status
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 12 months
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Secondary outcome [8]
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Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, 6 Months
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Secondary outcome [9]
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Mean Change From Baseline to 6 Months in Gait Speed
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, up to 6 Months
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Secondary outcome [10]
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Time to Revision Surgery
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline to revision surgery (up to 14.14 Months)
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Secondary outcome [11]
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Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, up to 6 Months
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Secondary outcome [12]
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Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, up to 6 Months
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Secondary outcome [13]
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Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, up to 6 Months
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Eligibility
Key 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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
122
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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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. - Penrith
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Recruitment hospital [2]
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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. - Heidelberg
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Recruitment hospital [3]
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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. - St Albans
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Recruitment hospital [4]
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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. - Nedlands
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Recruitment postcode(s) [1]
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2751 - Penrith
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Recruitment postcode(s) [2]
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3081 - Heidelberg
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Recruitment postcode(s) [3]
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3021 - St Albans
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Idaho
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Michigan
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Missouri
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Nebraska
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North Carolina
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North Dakota
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Ontario
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Aarhus
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Hillerod
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Koege
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Estonia
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Tartu
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Oulu
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Ahmedabad
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India
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Attavar, Mangalore
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India
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Bangalore
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India
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Hyderabaad
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India
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Nagpur
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India
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Vadodara
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Haifa
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Israel
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Jerusalem
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Aichi
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Chiba
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Fukuoka
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Fukushima
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Gunma
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Hiroshima
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Ibaraki
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Kagawa
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Nagano
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Niigata
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Ohita
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Osaka
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Saga
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Shimane
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Shizuoka
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Toyama
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Toyko
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Yamaguchi
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Yamanashi
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Korea, Republic of
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Seongnam-Si
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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New Zealand
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Christchurch
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Takapuna
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Wellington South
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Norway
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Toensberg
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Puerto Rico
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San Juan
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Spain
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Alcira
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Spain
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Barcelona
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Girona
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Spain
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Guadalajara
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Marbella
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Spain
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Pozuelo De Alarcon
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Sweden
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Malmo
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Sweden
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Mölndal
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Sweden
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Stockholm
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Taiwan
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Jhonghe City
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01473589
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Principal investigator
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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)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01473589
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