Effect of Teriparatide on Hip Fracture Healing
10 april 2015 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
- A 6-month double-blind treatment period [teriparatide 20 µg or placebo given once daily by SC injection]
- 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.
Studietyp
Interventionell
Inskrivning (Faktisk)
122
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New South Wales
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Penrith, New South Wales, Australien, 2751
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Victoria
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Heidelberg, Victoria, Australien, 3081
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St Albans, Victoria, Australien, 3021
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Western Australia
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Nedlands, Western Australia, Australien, 6009
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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
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Phoenix, Arizona, Förenta staterna, 85027
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Tucson, Arizona, Förenta staterna, 85712
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California
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La Mesa, California, Förenta staterna, 91942
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Laguna Hills, California, Förenta staterna, 92653
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Lancaster, California, Förenta staterna, 93534
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Pasadena, California, Förenta staterna, 91101
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Connecticut
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Danbury, Connecticut, Förenta staterna, 06810
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Florida
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Boca Raton, Florida, Förenta staterna, 33486
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Bradenton, Florida, Förenta staterna, 34209
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Miami, Florida, Förenta staterna, 33136
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Orlando, Florida, Förenta staterna, 32804
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Idaho
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Idaho Falls, Idaho, Förenta staterna, 83404
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Michigan
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Royal Oak, Michigan, Förenta staterna, 48073
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Missouri
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Columbia, Missouri, Förenta staterna, 65212
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Springfield, Missouri, Förenta staterna, 65804
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Montana
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Billings, Montana, Förenta staterna, 59101
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Great Falls, Montana, Förenta staterna, 59405
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68131
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North Carolina
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Asheville, North Carolina, Förenta staterna, 28801
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58103
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Pennsylvania
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York, Pennsylvania, Förenta staterna, 17405
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Texas
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Houston, Texas, Förenta staterna, 77043
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San Antonio, Texas, Förenta staterna, 78229
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Utah
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Salt Lake City, Utah, Förenta staterna, 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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Yamaguchi, Japan, 754-0002
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Yamanashi, Japan, 400-8506
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Ontario
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Newmarket, Ontario, Kanada, L3Y 2P9
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St. Catharines, Ontario, Kanada, L2R 5J7
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Quebec
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St-Jerome, Quebec, Kanada, J7Z 5T3
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Seongnam-Si, Korea, Republiken av, 463-707
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Seoul, Korea, Republiken av, 135 720
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Riga, Lettland, 1005
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Kaunas, Litauen, 44320
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Klaipeda, Litauen, 92228
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Vilnius, Litauen, 04130
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Toensberg, Norge, NO-3103
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Christchurch, Nya Zeeland, 8022
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Takapuna, Nya Zeeland, 0622
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Wellington South, Nya Zeeland, 6021
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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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Mölndal, Sverige, 43180
- 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.
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Stockholm, Sverige, SE-118 83
- 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.
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Jhonghe City, Taiwan, 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.
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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.
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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.
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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.
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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.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
Administreras en gång dagligen genom subkutan (SC) injektion i 6 månader
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Administreras genom SC-injektion
Administreras oralt
Administreras oralt
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Experimentell: Teriparatid
20 mikrogram (µg) administrerat en gång dagligen genom SC-injektion i 6 månader
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Administreras oralt
Administreras oralt
Administreras genom SC-injektion
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Andel deltagare utan revisionskirurgi vid 12 månader efter intern fixering av en lårbenshalsfraktur med lågt trauma
Tidsram: 12 månader
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Revisionskirurgi (re-operation) definierades som varje ytterligare kirurgiskt ingrepp utfört eller rekommenderat på platsen för indexproceduren, förutom de som var planerade vid tidpunkten för indexproceduren.
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12 månader
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Radiographic Evidence of Healing
Tidsram: Randomization up to 12 months
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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. |
Randomization up to 12 months
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Percentage of Participants With Pain Control During Ambulation
Tidsram: Up to 12 months
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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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Up to 12 months
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Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Tidsram: Up to 12 months
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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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Up to 12 months
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Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Tidsram: Up to 12 months
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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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Up to 12 months
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Percentage of Participants With Functional Evidence of Healing
Tidsram: 12 Months
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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. |
12 Months
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Percentage of Participants Able to Ambulate
Tidsram: Up to 12 months
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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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Up to 12 months
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Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Tidsram: Up to 12 months
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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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Up to 12 months
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Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Tidsram: Baseline, 6 Months
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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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Baseline, 6 Months
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Mean Change From Baseline to 6 Months in Gait Speed
Tidsram: Baseline, up to 6 Months
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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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Baseline, up to 6 Months
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Time to Revision Surgery
Tidsram: Baseline to revision surgery (up to 14.14 Months)
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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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Baseline to revision surgery (up to 14.14 Months)
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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
Tidsram: Baseline, up to 6 Months
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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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Baseline, up to 6 Months
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Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Tidsram: Baseline, up to 6 Months
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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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Baseline, up to 6 Months
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Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Tidsram: Baseline, up to 6 Months
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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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Baseline, up to 6 Months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2012
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
14 november 2011
Först inskickad som uppfyllde QC-kriterierna
14 november 2011
Första postat (Uppskatta)
17 november 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13467
- B3D-MC-GHDN (Annan identifierare: Eli Lilly and Company)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .