Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
13 februari 2009 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
428
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Brussels, België
- 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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Gent, België
- 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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Leuven, België
- 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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Aarhus, Denemarken
- 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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Oslo, Noorwegen
- 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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Graz, Oostenrijk
- 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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Vienna, Oostenrijk
- 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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Carolina, Puerto Rico
- 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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Ponce, Puerto Rico
- 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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California
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Loma Linda, California, Verenigde Staten
- 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, Verenigde Staten
- 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, Verenigde Staten
- 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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North Dakota
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Fargo, North Dakota, Verenigde Staten
- 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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Jamestown, North Dakota, Verenigde Staten
- 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, Verenigde Staten
- 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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
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20 micrograms/day, injection, 36 months
Andere namen:
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2002
Primaire voltooiing (Werkelijk)
1 juli 2006
Studie voltooiing (Werkelijk)
1 januari 2008
Studieregistratiedata
Eerst ingediend
13 januari 2003
Eerst ingediend dat voldeed aan de QC-criteria
13 januari 2003
Eerst geplaatst (Schatting)
14 januari 2003
Updates van studierecords
Laatste update geplaatst (Schatting)
12 maart 2009
Laatste update ingediend die voldeed aan QC-criteria
13 februari 2009
Laatst geverifieerd
1 februari 2009
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 6484
- B3D-US-GHBZ
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .