Effect of Teriparatide on Hip Fracture Healing
10 avril 2015 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
122
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New South Wales
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Penrith, New South Wales, Australie, 2751
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Victoria
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Heidelberg, Victoria, Australie, 3081
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St Albans, Victoria, Australie, 3021
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Western Australia
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Nedlands, Western Australia, Australie, 6009
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Ontario
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Newmarket, Ontario, Canada, L3Y 2P9
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St. Catharines, Ontario, Canada, L2R 5J7
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Quebec
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St-Jerome, Quebec, Canada, J7Z 5T3
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Seongnam-Si, Corée, République de, 463-707
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Seoul, Corée, République de, 135 720
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Aarhus, Danemark, 8000
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Hillerod, Danemark, Dk-3400
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Kobenhavn, Danemark, 2400
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Alcira, Espagne, 46600
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Girona, Espagne, 17007
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Guadalajara, Espagne, 19002
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Marbella, Espagne, 29600
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Pozuelo De Alarcon, Espagne, 28223
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Tartu, Estonie, 51014
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Oulu, Finlande, 90229
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Turku, Finlande, SF-20520
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Hong Kong, Hong Kong
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Ahmedabad, Inde, 532004
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Attavar, Mangalore, Inde, 575001
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Bangalore, Inde, 560 054
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Hyderabaad, Inde, 500033
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Nagpur, Inde, 444001
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Vadodara, Inde, 390018
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Haifa, Israël, 31096
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Jerusalem, Israël, 91240
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Aichi, Japon, 465-8620
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Chiba, Japon, 275-8580
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Fukuoka, Japon, 831-0016
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Fukushima, Japon, 961
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Gunma, Japon, 371-0014
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Hiroshima, Japon, 739-0696
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Ibaraki, Japon, 305-0854
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Japan, Japon, 399-8292
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Kagawa, Japon, 765-8507
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Nagano, Japon, 390-8510
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Niigata, Japon, 950-1197
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Ohita, Japon, 874-0011
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Osaka, Japon, 586-8521
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Saga, Japon, 840
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Shimane, Japon, 697-8511
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Shizuoka, Japon, 411-8611
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Toyama, Japon, 939-1395
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Toyko, Japon, 208-0011
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Yamaguchi, Japon, 754-0002
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Yamanashi, Japon, 400-8506
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Riga, Lettonie, 1005
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Kaunas, Lituanie, 44320
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Klaipeda, Lituanie, 92228
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Vilnius, Lituanie, 04130
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Toensberg, Norvège, NO-3103
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Christchurch, Nouvelle-Zélande, 8022
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Takapuna, Nouvelle-Zélande, 0622
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Wellington South, Nouvelle-Zélande, 6021
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San Juan, Porto Rico, 00936-5067
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Malmo, Suède, 205 02
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Mölndal, Suède, 43180
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Stockholm, Suède, SE-118 83
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Jhonghe City, Taïwan, 235
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Kaohsiung, Taïwan, 824
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Taichung, Taïwan, 40705
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Taichung City, Taïwan, 40201
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Taipei, Taïwan, 220
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Arizona
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Phoenix, Arizona, États-Unis, 85027
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Tucson, Arizona, États-Unis, 85712
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California
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La Mesa, California, États-Unis, 91942
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Laguna Hills, California, États-Unis, 92653
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Lancaster, California, États-Unis, 93534
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Pasadena, California, États-Unis, 91101
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Connecticut
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Danbury, Connecticut, États-Unis, 06810
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Florida
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Boca Raton, Florida, États-Unis, 33486
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Bradenton, Florida, États-Unis, 34209
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Miami, Florida, États-Unis, 33136
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Orlando, Florida, États-Unis, 32804
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Idaho
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Idaho Falls, Idaho, États-Unis, 83404
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Michigan
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Royal Oak, Michigan, États-Unis, 48073
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Missouri
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Columbia, Missouri, États-Unis, 65212
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Springfield, Missouri, États-Unis, 65804
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Montana
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Billings, Montana, États-Unis, 59101
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Great Falls, Montana, États-Unis, 59405
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Nebraska
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Omaha, Nebraska, États-Unis, 68131
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North Carolina
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Asheville, North Carolina, États-Unis, 28801
- 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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North Dakota
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Fargo, North Dakota, États-Unis, 58103
- 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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Pennsylvania
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York, Pennsylvania, États-Unis, 17405
- 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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Texas
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Houston, Texas, États-Unis, 77043
- 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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San Antonio, Texas, États-Unis, 78229
- 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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Utah
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Salt Lake City, Utah, États-Unis, 84108
- 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
Administré une fois par jour par injection sous-cutanée (SC) pendant 6 mois
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Administré par injection SC
Administré par voie orale
Administré par voie orale
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Expérimental: Tériparatide
20 microgrammes (µg) administrés une fois par jour par injection SC pendant 6 mois
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Administré par voie orale
Administré par voie orale
Administré par injection SC
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pourcentage de participants sans chirurgie de révision 12 mois après la fixation interne d'une fracture du col du fémur à faible traumatisme
Délai: 12 mois
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La chirurgie de révision (ré-opération) a été définie comme toute intervention chirurgicale supplémentaire réalisée ou recommandée sur le site de la procédure index, à l'exception de celles qui étaient prévues au moment de la procédure index.
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12 mois
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Radiographic Evidence of Healing
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2012
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 décembre 2013
Dates d'inscription aux études
Première soumission
14 novembre 2011
Première soumission répondant aux critères de contrôle qualité
14 novembre 2011
Première publication (Estimation)
17 novembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 avril 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 avril 2015
Dernière vérification
1 avril 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Blessures et Blessures
- Blessures aux jambes
- Fracture fémorale
- Blessures à la hanche
- Fracture de la hanche
- Fractures, Os
- Fractures du col fémoral
- Effets physiologiques des médicaments
- Micronutriments
- Vitamines
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Vitamine D
- Calcium
- Tériparatide
Autres numéros d'identification d'étude
- 13467
- B3D-MC-GHDN (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .