Effect of Teriparatide on Hip Fracture Healing
10 de abril de 2015 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
122
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New South Wales
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Penrith, New South Wales, Australia, 2751
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Victoria
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Heidelberg, Victoria, Australia, 3081
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St Albans, Victoria, Australia, 3021
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Ontario
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Newmarket, Ontario, Canadá, L3Y 2P9
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St. Catharines, Ontario, Canadá, L2R 5J7
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Quebec
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St-Jerome, Quebec, Canadá, J7Z 5T3
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Seongnam-Si, Corea, república de, 463-707
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Seoul, Corea, república de, 135 720
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Aarhus, Dinamarca, 8000
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Hillerod, Dinamarca, Dk-3400
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Kobenhavn, Dinamarca, 2400
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Koege, Dinamarca, 4600
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Alcira, España, 46600
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Barcelona, España, 08025
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Girona, España, 17007
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Guadalajara, España, 19002
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Marbella, España, 29600
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Pozuelo De Alarcon, España, 28223
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Arizona
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Phoenix, Arizona, Estados Unidos, 85027
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Tucson, Arizona, Estados Unidos, 85712
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California
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La Mesa, California, Estados Unidos, 91942
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Laguna Hills, California, Estados Unidos, 92653
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Lancaster, California, Estados Unidos, 93534
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Pasadena, California, Estados Unidos, 91101
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
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Bradenton, Florida, Estados Unidos, 34209
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Miami, Florida, Estados Unidos, 33136
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Orlando, Florida, Estados Unidos, 32804
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
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Michigan
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Royal Oak, Michigan, Estados Unidos, 48073
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Missouri
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Columbia, Missouri, Estados Unidos, 65212
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Springfield, Missouri, Estados Unidos, 65804
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Montana
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Billings, Montana, Estados Unidos, 59101
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Great Falls, Montana, Estados Unidos, 59405
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28801
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58103
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Pennsylvania
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York, Pennsylvania, Estados Unidos, 17405
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Texas
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Houston, Texas, Estados Unidos, 77043
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San Antonio, Texas, Estados Unidos, 78229
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Utah
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Salt Lake City, Utah, Estados Unidos, 84108
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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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Hong Kong, Hong Kong
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Ahmedabad, India, 532004
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Attavar, Mangalore, India, 575001
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Bangalore, India, 560 054
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Hyderabaad, India, 500033
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Nagpur, India, 444001
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Vadodara, India, 390018
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Haifa, Israel, 31096
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Jerusalem, Israel, 91240
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Aichi, Japón, 465-8620
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Chiba, Japón, 275-8580
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Fukuoka, Japón, 831-0016
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Fukushima, Japón, 961
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Gunma, Japón, 371-0014
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Hiroshima, Japón, 739-0696
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Ibaraki, Japón, 305-0854
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Japan, Japón, 399-8292
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Kagawa, Japón, 765-8507
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Nagano, Japón, 390-8510
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Niigata, Japón, 950-1197
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Ohita, Japón, 874-0011
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Osaka, Japón, 586-8521
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Saga, Japón, 840
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Shimane, Japón, 697-8511
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Shizuoka, Japón, 411-8611
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Toyama, Japón, 939-1395
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Toyko, Japón, 208-0011
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Yamaguchi, Japón, 754-0002
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Yamanashi, Japón, 400-8506
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Riga, Letonia, 1005
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Kaunas, Lituania, 44320
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Klaipeda, Lituania, 92228
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Vilnius, Lituania, 04130
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Toensberg, Noruega, NO-3103
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Christchurch, Nueva Zelanda, 8022
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Takapuna, Nueva Zelanda, 0622
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Wellington South, Nueva Zelanda, 6021
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San Juan, Puerto Rico, 00936-5067
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Malmo, Suecia, 205 02
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Mölndal, Suecia, 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, Suecia, SE-118 83
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Jhonghe City, Taiwán, 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, Taiwán, 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, Taiwán, 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, Taiwán, 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, Taiwán, 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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
Administrado una vez al día por inyección subcutánea (SC) durante 6 meses
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Administrado por inyección SC
Administrado por vía oral
Administrado por vía oral
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Experimental: Teriparatida
20 microgramos (µg) administrados una vez al día mediante inyección SC durante 6 meses
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Administrado por vía oral
Administrado por vía oral
Administrado por inyección SC
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Porcentaje de participantes sin cirugía de revisión a los 12 meses después de la fijación interna de una fractura de cuello femoral por traumatismo leve
Periodo de tiempo: 12 meses
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La cirugía de revisión (reoperación) se definió como cualquier intervención quirúrgica adicional realizada o recomendada en el sitio del procedimiento índice, excepto aquellas que estaban planificadas en el momento del procedimiento índice.
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12 meses
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Radiographic Evidence of Healing
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2012
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
14 de noviembre de 2011
Publicado por primera vez (Estimar)
17 de noviembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de abril de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
10 de abril de 2015
Última verificación
1 de abril de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Lesiones en las piernas
- Fracturas Femorales
- Lesiones de cadera
- Fracturas de cadera
- Fracturas, Hueso
- Fracturas del cuello femoral
- Efectos fisiológicos de las drogas
- Micronutrientes
- Vitaminas
- Agentes de conservación de la densidad ósea
- Hormonas y agentes reguladores del calcio
- Vitamina D
- Calcio
- Teriparatida
Otros números de identificación del estudio
- 13467
- B3D-MC-GHDN (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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