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Effect of Teriparatide on Hip Fracture Healing

10 kwietnia 2015 zaktualizowane przez: 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).

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

122

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • New South Wales
      • Penrith, New South Wales, Australia, 2751
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    • Victoria
      • Heidelberg, Victoria, Australia, 3081
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      • St Albans, Victoria, Australia, 3021
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    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
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      • Aarhus, Dania, 8000
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      • Hillerod, Dania, Dk-3400
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      • Kobenhavn, Dania, 2400
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      • Koege, Dania, 4600
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      • Tartu, Estonia, 51014
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      • Oulu, Finlandia, 90229
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      • Turku, Finlandia, SF-20520
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      • Alcira, Hiszpania, 46600
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      • Barcelona, Hiszpania, 08025
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      • Girona, Hiszpania, 17007
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      • Guadalajara, Hiszpania, 19002
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      • Marbella, Hiszpania, 29600
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      • Pozuelo De Alarcon, Hiszpania, 28223
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      • Hong Kong, Hongkong
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      • Ahmedabad, Indie, 532004
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      • Attavar, Mangalore, Indie, 575001
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      • Bangalore, Indie, 560 054
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      • Hyderabaad, Indie, 500033
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      • Nagpur, Indie, 444001
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      • Vadodara, Indie, 390018
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      • Haifa, Izrael, 31096
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      • Jerusalem, Izrael, 91240
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      • Aichi, Japonia, 465-8620
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      • Chiba, Japonia, 275-8580
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      • Fukuoka, Japonia, 831-0016
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      • Fukushima, Japonia, 961
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      • Gunma, Japonia, 371-0014
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      • Hiroshima, Japonia, 739-0696
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      • Ibaraki, Japonia, 305-0854
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      • Japan, Japonia, 399-8292
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      • Kagawa, Japonia, 765-8507
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      • Nagano, Japonia, 390-8510
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      • Niigata, Japonia, 950-1197
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      • Ohita, Japonia, 874-0011
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      • Osaka, Japonia, 586-8521
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      • Saga, Japonia, 840
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      • Shimane, Japonia, 697-8511
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      • Shizuoka, Japonia, 411-8611
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      • Toyama, Japonia, 939-1395
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      • Toyko, Japonia, 208-0011
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      • Yamaguchi, Japonia, 754-0002
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      • Yamanashi, Japonia, 400-8506
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    • Ontario
      • Newmarket, Ontario, Kanada, L3Y 2P9
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      • St. Catharines, Ontario, Kanada, L2R 5J7
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    • Quebec
      • St-Jerome, Quebec, Kanada, J7Z 5T3
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      • Kaunas, Litwa, 44320
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      • Klaipeda, Litwa, 92228
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      • Vilnius, Litwa, 04130
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      • Toensberg, Norwegia, NO-3103
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      • Christchurch, Nowa Zelandia, 8022
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      • Takapuna, Nowa Zelandia, 0622
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      • Wellington South, Nowa Zelandia, 6021
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      • San Juan, Portoryko, 00936-5067
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      • Seongnam-Si, Republika Korei, 463-707
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      • Seoul, Republika Korei, 135 720
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    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85027
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      • Tucson, Arizona, Stany Zjednoczone, 85712
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    • California
      • La Mesa, California, Stany Zjednoczone, 91942
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      • Laguna Hills, California, Stany Zjednoczone, 92653
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      • Lancaster, California, Stany Zjednoczone, 93534
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      • Pasadena, California, Stany Zjednoczone, 91101
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    • Connecticut
      • Danbury, Connecticut, Stany Zjednoczone, 06810
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    • Florida
      • Boca Raton, Florida, Stany Zjednoczone, 33486
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      • Bradenton, Florida, Stany Zjednoczone, 34209
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      • Miami, Florida, Stany Zjednoczone, 33136
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      • Orlando, Florida, Stany Zjednoczone, 32804
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    • Idaho
      • Idaho Falls, Idaho, Stany Zjednoczone, 83404
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    • Michigan
      • Royal Oak, Michigan, Stany Zjednoczone, 48073
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    • Missouri
      • Columbia, Missouri, Stany Zjednoczone, 65212
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      • Springfield, Missouri, Stany Zjednoczone, 65804
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    • Montana
      • Billings, Montana, Stany Zjednoczone, 59101
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      • Great Falls, Montana, Stany Zjednoczone, 59405
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    • Nebraska
      • Omaha, Nebraska, Stany Zjednoczone, 68131
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    • North Carolina
      • Asheville, North Carolina, Stany Zjednoczone, 28801
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    • North Dakota
      • Fargo, North Dakota, Stany Zjednoczone, 58103
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    • Pennsylvania
      • York, Pennsylvania, Stany Zjednoczone, 17405
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    • Texas
      • Houston, Texas, Stany Zjednoczone, 77043
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      • San Antonio, Texas, Stany Zjednoczone, 78229
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    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84108
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      • Malmo, Szwecja, 205 02
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      • Mölndal, Szwecja, 43180
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      • Stockholm, Szwecja, SE-118 83
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      • Jhonghe City, Tajwan, 235
        • 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.
      • Kaohsiung, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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.
      • Riga, Łotwa, 1005
        • 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.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Podawany raz dziennie we wstrzyknięciu podskórnym (SC) przez 6 miesięcy
Podawany przez wstrzyknięcie SC
Podawany doustnie
Podawany doustnie
Eksperymentalny: Teryparatyd
20 mikrogramów (µg) podawane raz dziennie we wstrzyknięciu podskórnym przez 6 miesięcy
Podawany doustnie
Podawany doustnie
Podawany przez wstrzyknięcie SC
Inne nazwy:
  • Forteo
  • LY333334
  • Forsteo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Odsetek uczestników bez operacji rewizyjnej po 12 miesiącach od wewnętrznego zespolenia złamania szyjki kości udowej o niskim urazie
Ramy czasowe: 12 miesięcy
Operację rewizyjną (reoperację) zdefiniowano jako każdą dodatkową interwencję chirurgiczną wykonaną lub zalecaną w miejscu zabiegu indeksowania, z wyjątkiem tych, które były zaplanowane w czasie zabiegu indeksowania.
12 miesięcy

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Radiographic Evidence of Healing
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2012

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2013

Ukończenie studiów (Rzeczywisty)

1 grudnia 2013

Daty rejestracji na studia

Pierwszy przesłany

14 listopada 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 listopada 2011

Pierwszy wysłany (Oszacować)

17 listopada 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

16 kwietnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 kwietnia 2015

Ostatnia weryfikacja

1 kwietnia 2015

Więcej informacji

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Złamanie szyjki kości udowej

Badania kliniczne na Placebo

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