Effect of Teriparatide on Hip Fracture Healing
10. dubna 2015 aktualizováno: 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).
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
122
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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New South Wales
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Penrith, New South Wales, Austrálie, 2751
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Victoria
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Heidelberg, Victoria, Austrálie, 3081
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St Albans, Victoria, Austrálie, 3021
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Western Australia
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Nedlands, Western Australia, Austrálie, 6009
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Aarhus, Dánsko, 8000
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Hillerod, Dánsko, Dk-3400
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Kobenhavn, Dánsko, 2400
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Koege, Dánsko, 4600
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Tartu, Estonsko, 51014
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Oulu, Finsko, 90229
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Turku, Finsko, SF-20520
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Hong Kong, Hongkong
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Ahmedabad, Indie, 532004
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Attavar, Mangalore, Indie, 575001
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Bangalore, Indie, 560 054
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Hyderabaad, Indie, 500033
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Nagpur, Indie, 444001
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Vadodara, Indie, 390018
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Haifa, Izrael, 31096
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Jerusalem, Izrael, 91240
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Aichi, Japonsko, 465-8620
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Chiba, Japonsko, 275-8580
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Fukuoka, Japonsko, 831-0016
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Fukushima, Japonsko, 961
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Gunma, Japonsko, 371-0014
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Hiroshima, Japonsko, 739-0696
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Ibaraki, Japonsko, 305-0854
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Japan, Japonsko, 399-8292
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Kagawa, Japonsko, 765-8507
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Nagano, Japonsko, 390-8510
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Niigata, Japonsko, 950-1197
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Ohita, Japonsko, 874-0011
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Osaka, Japonsko, 586-8521
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Saga, Japonsko, 840
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Shimane, Japonsko, 697-8511
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Shizuoka, Japonsko, 411-8611
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Toyama, Japonsko, 939-1395
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Toyko, Japonsko, 208-0011
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Yamaguchi, Japonsko, 754-0002
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Yamanashi, Japonsko, 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, Korejská republika, 463-707
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Seoul, Korejská republika, 135 720
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Kaunas, Litva, 44320
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Klaipeda, Litva, 92228
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Vilnius, Litva, 04130
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Riga, Lotyšsko, 1005
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Toensberg, Norsko, NO-3103
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Christchurch, Nový Zéland, 8022
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Takapuna, Nový Zéland, 0622
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Wellington South, Nový Zéland, 6021
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San Juan, Portoriko, 00936-5067
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Arizona
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Phoenix, Arizona, Spojené státy, 85027
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Tucson, Arizona, Spojené státy, 85712
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California
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La Mesa, California, Spojené státy, 91942
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Laguna Hills, California, Spojené státy, 92653
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Lancaster, California, Spojené státy, 93534
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Pasadena, California, Spojené státy, 91101
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Connecticut
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Danbury, Connecticut, Spojené státy, 06810
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Florida
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Boca Raton, Florida, Spojené státy, 33486
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Bradenton, Florida, Spojené státy, 34209
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Miami, Florida, Spojené státy, 33136
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Orlando, Florida, Spojené státy, 32804
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Idaho
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Idaho Falls, Idaho, Spojené státy, 83404
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Michigan
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Royal Oak, Michigan, Spojené státy, 48073
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Missouri
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Columbia, Missouri, Spojené státy, 65212
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Springfield, Missouri, Spojené státy, 65804
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Montana
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Billings, Montana, Spojené státy, 59101
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Great Falls, Montana, Spojené státy, 59405
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Nebraska
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Omaha, Nebraska, Spojené státy, 68131
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North Carolina
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Asheville, North Carolina, Spojené státy, 28801
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North Dakota
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Fargo, North Dakota, Spojené státy, 58103
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Pennsylvania
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York, Pennsylvania, Spojené státy, 17405
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Texas
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Houston, Texas, Spojené státy, 77043
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San Antonio, Texas, Spojené státy, 78229
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Utah
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Salt Lake City, Utah, Spojené státy, 84108
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Jhonghe City, Tchaj-wan, 235
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Kaohsiung, Tchaj-wan, 824
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Taichung, Tchaj-wan, 40705
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Taichung City, Tchaj-wan, 40201
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Taipei, Tchaj-wan, 220
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Alcira, Španělsko, 46600
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Barcelona, Španělsko, 08025
- 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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Girona, Španělsko, 17007
- 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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Guadalajara, Španělsko, 19002
- 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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Marbella, Španělsko, 29600
- 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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Pozuelo De Alarcon, Španělsko, 28223
- 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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Malmo, Švédsko, 205 02
- 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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Mölndal, Švédsko, 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, Švédsko, 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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: Placebo
Podává se jednou denně subkutánní (SC) injekcí po dobu 6 měsíců
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Podává se SC injekcí
Podává se ústně
Podává se ústně
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Experimentální: Teriparatid
20 mikrogramů (µg) podávaných jednou denně SC injekcí po dobu 6 měsíců
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Podává se ústně
Podává se ústně
Podává se SC injekcí
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Procento účastníků bez revizní operace za 12 měsíců po vnitřní fixaci nízkotraumatické zlomeniny krčku stehenní kosti
Časové okno: 12 měsíců
|
Revizní operace (reoperace) byla definována jako jakákoli další chirurgická intervence provedená nebo doporučená v místě indexového výkonu, s výjimkou těch, které byly plánovány v době indexového výkonu.
|
12 měsíců
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Radiographic Evidence of Healing
Časové okno: Randomization up to 12 months
|
The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100. |
Randomization up to 12 months
|
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Percentage of Participants With Pain Control During Ambulation
Časové okno: Up to 12 months
|
The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life.
NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test.
Pain was measured by an 11-point Likert scale.
The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain.
Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline.
Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 12 Months
|
Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100. |
12 Months
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Percentage of Participants Able to Ambulate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, up to 6 Months
|
SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale.
LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
|
Baseline, up to 6 Months
|
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Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Časové okno: Baseline, up to 6 Months
|
WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function.
Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale.
LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
|
Baseline, up to 6 Months
|
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Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2012
Primární dokončení (Aktuální)
1. prosince 2013
Dokončení studie (Aktuální)
1. prosince 2013
Termíny zápisu do studia
První předloženo
14. listopadu 2011
První předloženo, které splnilo kritéria kontroly kvality
14. listopadu 2011
První zveřejněno (Odhad)
17. listopadu 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
16. dubna 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. dubna 2015
Naposledy ověřeno
1. dubna 2015
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 13467
- B3D-MC-GHDN (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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