Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
13. Februar 2009 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
428
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Brussels, Belgien
- 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, Belgien
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Leuven, Belgien
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Aarhus, Dänemark
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Oslo, Norwegen
- 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
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Ponce, Puerto Rico
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California
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Loma Linda, California, Vereinigte Staaten
- 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, Vereinigte Staaten
- 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, Vereinigte Staaten
- 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, Vereinigte Staaten
- 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, Vereinigte Staaten
- 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, Vereinigte Staaten
- 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, Österreich
- 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, Österreich
- 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2002
Primärer Abschluss (Tatsächlich)
1. Juli 2006
Studienabschluss (Tatsächlich)
1. Januar 2008
Studienanmeldedaten
Zuerst eingereicht
13. Januar 2003
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Januar 2003
Zuerst gepostet (Schätzen)
14. Januar 2003
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
12. März 2009
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Februar 2009
Zuletzt verifiziert
1. Februar 2009
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 6484
- B3D-US-GHBZ
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