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Effect of Teriparatide on Hip Fracture Healing

10. april 2015 opdateret af: Eli Lilly and Company

Effect of Teriparatide on Femoral Neck Fracture Healing

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).

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

122

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New South Wales
      • Penrith, New South Wales, Australien, 2751
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    • Victoria
      • Heidelberg, Victoria, Australien, 3081
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      • St Albans, Victoria, Australien, 3021
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    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
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    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
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      • St. Catharines, Ontario, Canada, L2R 5J7
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    • Quebec
      • St-Jerome, Quebec, Canada, J7Z 5T3
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      • Aarhus, Danmark, 8000
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      • Hillerod, Danmark, Dk-3400
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      • Kobenhavn, Danmark, 2400
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      • Koege, Danmark, 4600
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      • Tartu, Estland, 51014
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      • Oulu, Finland, 90229
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      • Turku, Finland, SF-20520
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    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85027
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      • Tucson, Arizona, Forenede Stater, 85712
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    • California
      • La Mesa, California, Forenede Stater, 91942
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      • Laguna Hills, California, Forenede Stater, 92653
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      • Lancaster, California, Forenede Stater, 93534
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      • Pasadena, California, Forenede Stater, 91101
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    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
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    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
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      • Bradenton, Florida, Forenede Stater, 34209
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      • Miami, Florida, Forenede Stater, 33136
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      • Orlando, Florida, Forenede Stater, 32804
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    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
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    • Michigan
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    • Missouri
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      • Springfield, Missouri, Forenede Stater, 65804
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    • Montana
      • Billings, Montana, Forenede Stater, 59101
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      • Great Falls, Montana, Forenede Stater, 59405
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    • Nebraska
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    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
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    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
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    • Pennsylvania
      • York, Pennsylvania, Forenede Stater, 17405
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    • Texas
      • Houston, Texas, Forenede Stater, 77043
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      • San Antonio, Texas, Forenede Stater, 78229
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    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
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      • Hong Kong, Hong Kong
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      • Ahmedabad, Indien, 532004
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      • Attavar, Mangalore, Indien, 575001
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      • Bangalore, Indien, 560 054
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      • Hyderabaad, Indien, 500033
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      • Nagpur, Indien, 444001
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      • Vadodara, Indien, 390018
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      • Haifa, Israel, 31096
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      • Jerusalem, Israel, 91240
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      • Aichi, Japan, 465-8620
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      • Chiba, Japan, 275-8580
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      • Fukuoka, Japan, 831-0016
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      • Fukushima, Japan, 961
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      • Gunma, Japan, 371-0014
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      • Hiroshima, Japan, 739-0696
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      • Ibaraki, Japan, 305-0854
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      • Japan, Japan, 399-8292
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      • Kagawa, Japan, 765-8507
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      • Nagano, Japan, 390-8510
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      • Niigata, Japan, 950-1197
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      • Ohita, Japan, 874-0011
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      • Osaka, Japan, 586-8521
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      • Saga, Japan, 840
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      • Shimane, Japan, 697-8511
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      • Shizuoka, Japan, 411-8611
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      • Toyama, Japan, 939-1395
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      • Toyko, Japan, 208-0011
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      • Seoul, Korea, Republikken, 135 720
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      • Riga, Letland, 1005
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      • Kaunas, Litauen, 44320
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      • Klaipeda, Litauen, 92228
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      • Christchurch, New Zealand, 8022
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      • Wellington South, New Zealand, 6021
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      • Toensberg, Norge, NO-3103
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      • San Juan, Puerto Rico, 00936-5067
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      • Alcira, Spanien, 46600
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      • Barcelona, Spanien, 08025
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      • Girona, Spanien, 17007
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      • Guadalajara, Spanien, 19002
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      • Marbella, Spanien, 29600
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      • Pozuelo De Alarcon, Spanien, 28223
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      • Malmo, Sverige, 205 02
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      • Stockholm, Sverige, SE-118 83
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      • Kaohsiung, Taiwan, 824
        • 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.
      • Taichung, Taiwan, 40705
        • 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.
      • Taichung City, Taiwan, 40201
        • 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.
      • Taipei, Taiwan, 220
        • 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.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Administreret én gang dagligt ved subkutan (SC) injektion i 6 måneder
Administreret ved SC-injektion
Indgives oralt
Indgives oralt
Eksperimentel: Teriparatid
20 mikrogram (µg) administreret én gang dagligt ved SC-injektion i 6 måneder
Indgives oralt
Indgives oralt
Administreret ved SC-injektion
Andre navne:
  • Forteo
  • LY333334
  • Forsteo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere uden revisionskirurgi ved 12 måneder efter intern fiksering af et lårhalsfraktur med lavt traume
Tidsramme: 12 måneder
Revisionskirurgi (re-operation) blev defineret som enhver yderligere kirurgisk indgreb udført eller anbefalet på stedet for indeksproceduren, undtagen dem, der var planlagt på tidspunktet for indeksproceduren.
12 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Radiographic Evidence of Healing
Tidsramme: 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.

Randomization up to 12 months
Percentage of Participants With Pain Control During Ambulation
Tidsramme: 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.
Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Tidsramme: 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.
Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Tidsramme: 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.
Up to 12 months
Percentage of Participants With Functional Evidence of Healing
Tidsramme: 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.

12 Months
Percentage of Participants Able to Ambulate
Tidsramme: 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.
Up to 12 months
Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Tidsramme: 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.
Up to 12 months
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Tidsramme: 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.
Baseline, 6 Months
Mean Change From Baseline to 6 Months in Gait Speed
Tidsramme: 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.
Baseline, up to 6 Months
Time to Revision Surgery
Tidsramme: 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.
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
Tidsramme: 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.
Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Tidsramme: 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.
Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Tidsramme: 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.
Baseline, up to 6 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2012

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

14. november 2011

Først indsendt, der opfyldte QC-kriterier

14. november 2011

Først opslået (Skøn)

17. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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