Effect of Teriparatide on Hip Fracture Healing
10 aprile 2015 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
122
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, 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, Corea, Repubblica di, 463-707
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Seoul, Corea, Repubblica di, 135 720
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Aarhus, Danimarca, 8000
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Hillerod, Danimarca, Dk-3400
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Kobenhavn, Danimarca, 2400
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Koege, Danimarca, 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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Aichi, Giappone, 465-8620
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Chiba, Giappone, 275-8580
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Fukuoka, Giappone, 831-0016
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Fukushima, Giappone, 961
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Gunma, Giappone, 371-0014
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Hiroshima, Giappone, 739-0696
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Ibaraki, Giappone, 305-0854
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Japan, Giappone, 399-8292
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Kagawa, Giappone, 765-8507
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Nagano, Giappone, 390-8510
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Niigata, Giappone, 950-1197
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Ohita, Giappone, 874-0011
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Osaka, Giappone, 586-8521
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Saga, Giappone, 840
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Shimane, Giappone, 697-8511
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Shizuoka, Giappone, 411-8611
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Toyama, Giappone, 939-1395
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Toyko, Giappone, 208-0011
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Yamaguchi, Giappone, 754-0002
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Yamanashi, Giappone, 400-8506
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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, Israele, 31096
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Jerusalem, Israele, 91240
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Riga, Lettonia, 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, Norvegia, NO-3103
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Christchurch, Nuova Zelanda, 8022
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Takapuna, Nuova Zelanda, 0622
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Wellington South, Nuova Zelanda, 6021
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San Juan, Porto Rico, 00936-5067
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Alcira, Spagna, 46600
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Barcelona, Spagna, 08025
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Girona, Spagna, 17007
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Guadalajara, Spagna, 19002
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Marbella, Spagna, 29600
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Pozuelo De Alarcon, Spagna, 28223
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Arizona
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Phoenix, Arizona, Stati Uniti, 85027
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Tucson, Arizona, Stati Uniti, 85712
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California
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La Mesa, California, Stati Uniti, 91942
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Laguna Hills, California, Stati Uniti, 92653
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Lancaster, California, Stati Uniti, 93534
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Pasadena, California, Stati Uniti, 91101
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Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
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Florida
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Boca Raton, Florida, Stati Uniti, 33486
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Bradenton, Florida, Stati Uniti, 34209
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Miami, Florida, Stati Uniti, 33136
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Orlando, Florida, Stati Uniti, 32804
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404
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Michigan
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Royal Oak, Michigan, Stati Uniti, 48073
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Missouri
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Columbia, Missouri, Stati Uniti, 65212
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Springfield, Missouri, Stati Uniti, 65804
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Montana
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Billings, Montana, Stati Uniti, 59101
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Great Falls, Montana, Stati Uniti, 59405
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68131
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28801
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North Dakota
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Fargo, North Dakota, Stati Uniti, 58103
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Pennsylvania
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York, Pennsylvania, Stati Uniti, 17405
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Texas
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Houston, Texas, Stati Uniti, 77043
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San Antonio, Texas, Stati Uniti, 78229
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Utah
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Salt Lake City, Utah, Stati Uniti, 84108
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Malmo, Svezia, 205 02
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Mölndal, Svezia, 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, Svezia, 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
50 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: Placebo
Somministrato una volta al giorno per iniezione sottocutanea (SC) per 6 mesi
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Somministrato mediante iniezione SC
Somministrato per via orale
Somministrato per via orale
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Sperimentale: Teriparatide
20 microgrammi (µg) somministrati una volta al giorno mediante iniezione SC per 6 mesi
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Somministrato per via orale
Somministrato per via orale
Somministrato mediante iniezione SC
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentuale di partecipanti senza chirurgia di revisione a 12 mesi dopo la fissazione interna di una frattura del collo femorale a basso trauma
Lasso di tempo: 12 mesi
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La chirurgia di revisione (reintervento) è stata definita come qualsiasi intervento chirurgico aggiuntivo eseguito o raccomandato nel sito della procedura indice, ad eccezione di quelli pianificati al momento della procedura indice.
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12 mesi
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With Radiographic Evidence of Healing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Up to 12 months
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Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Lasso di tempo: 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
Lasso di tempo: 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.
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Baseline, up to 6 Months
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Time to Revision Surgery
Lasso di tempo: 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.
|
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
Lasso di tempo: 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)
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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Baseline, up to 6 Months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2012
Completamento primario (Effettivo)
1 dicembre 2013
Completamento dello studio (Effettivo)
1 dicembre 2013
Date di iscrizione allo studio
Primo inviato
14 novembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
14 novembre 2011
Primo Inserito (Stima)
17 novembre 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 aprile 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 aprile 2015
Ultimo verificato
1 aprile 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Ferite e lesioni
- Lesioni alla gamba
- Fratture femorali
- Lesioni all'anca
- Fratture dell'anca
- Fratture, ossa
- Fratture del collo del femore
- Effetti fisiologici delle droghe
- Micronutrienti
- Vitamine
- Agenti di conservazione della densità ossea
- Ormoni e agenti regolatori del calcio
- Vitamina D
- Calcio
- Teriparatide
Altri numeri di identificazione dello studio
- 13467
- B3D-MC-GHDN (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Frattura del collo del femore
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