Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
13. února 2009 aktualizováno: Eli Lilly and Company
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures.
Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma.
When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis."
This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
428
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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Brussels, Belgie
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Gent, Belgie
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Leuven, Belgie
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Aarhus, Dánsko
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Oslo, Norsko
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Carolina, Portoriko
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Ponce, Portoriko
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Graz, Rakousko
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Vienna, Rakousko
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California
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Loma Linda, California, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Palo Alto, California, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Colorado
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Aurora, Colorado, Spojené státy
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North Dakota
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Fargo, North Dakota, Spojené státy
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Jamestown, North Dakota, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 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
21 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Men or women age 21 years or older
- Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
Exclusion Criteria:
- Taking bisphosphonates within past 6 months
- More than 30 micrograms/day of estradiol or equivalent in past 3 months
- History of alcoholism or drug abuse in past year
- Pregnant women or nursing mothers
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: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
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20 micrograms/day, injection, 36 months
Ostatní jména:
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
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Aktivní komparátor: B
Alendronate 10 mg/day oral plus injection placebo, 36 months
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Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
10 mg/day, oral, 36 months
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Časové okno: 18 month endpoint
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change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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18 month endpoint
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Časové okno: 18 month endpoint
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change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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18 month endpoint
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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Časové okno: 3, 6, 12, 18, 24, 36 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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3, 6, 12, 18, 24, 36 months
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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Časové okno: 3, 6, 12, and 18 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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3, 6, 12, and 18 months
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Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Časové okno: 24 and 36 months and Endpoint at 36 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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24 and 36 months and Endpoint at 36 months
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Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Časové okno: 18, 24, 36 months, and 18 and 36 month endpoints
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change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
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18, 24, 36 months, and 18 and 36 month endpoints
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Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Časové okno: 18, 24, 36 months, and 18 and 36 month endpoints
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change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
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18, 24, 36 months, and 18 and 36 month endpoints
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Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Časové okno: 12, 18, 24, and 36 months
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change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
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12, 18, 24, and 36 months
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Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Časové okno: 12, 18, 24, and 36 months
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change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
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12, 18, 24, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Časové okno: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Časové okno: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Časové okno: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Časové okno: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Časové okno: 1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Časové okno: 36 months
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Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
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36 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.
- Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.
- Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.
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. listopadu 2002
Primární dokončení (Aktuální)
1. července 2006
Dokončení studie (Aktuální)
1. ledna 2008
Termíny zápisu do studia
První předloženo
13. ledna 2003
První předloženo, které splnilo kritéria kontroly kvality
13. ledna 2003
První zveřejněno (Odhad)
14. ledna 2003
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
12. března 2009
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. února 2009
Naposledy ověřeno
1. února 2009
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 6484
- B3D-US-GHBZ
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 .