- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00343252
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
20. Mai 2011 aktualisiert von: Eli Lilly and Company
The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
712
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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Buenos Aires, Argentinien, C1117ABH
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Malvern East, Australien, 3145
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New South Wales
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Kogarah, New South Wales, Australien, 2217
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Randwick, Sydney, New South Wales, Australien, 2031
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Queensland
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Maroochydore, Queensland, Australien, 4558
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South Australia
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Keswick, South Australia, Australien, 5035
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Brussels, Belgien, 1180
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Gent, Belgien, 9000
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Gozee, Belgien, 6534
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Leuven, Belgien, 3000
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Liege, Belgien, 4000
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Tienen, Belgien, 3300
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Yvoir, Belgien, 5530
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Campinas, Brasilien, 13073-350
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Rio De Janeiro, Brasilien, 22271-100
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Sao Paulo, Brasilien, 01246-903
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Braunfels, Deutschland, 35619
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Frankfurt, Deutschland, 60528
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Hamburg, Deutschland, 20354
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Heidelberg, Deutschland, D-69120
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Heinsberg, Deutschland, 52525
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Leipzig, Deutschland, 04207
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Marburg, Deutschland, 35033
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München, Deutschland, 80335
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Amiens, Frankreich, 80084
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Orleans, Frankreich, 45000
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Paris, Frankreich, 75679
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Poitiers, Frankreich, 86000
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Siena, Italien, 53100
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Treviglio, Italien, 24047
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Valeggio Sul Mincio, Italien, 37067
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British Columbia
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Vancouver, British Columbia, Kanada, V6H 3X8
- 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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Manitoba
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Winnipeg, Manitoba, Kanada, R3A 1M3
- 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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Ontario
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Hamilton, Ontario, Kanada, L8N 1Y2
- 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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London, Ontario, Kanada, N6A 4V2
- 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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Quebec
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Montreal, Quebec, Kanada, H3A 1A1
- 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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Sainte-Foy, Quebec, Kanada, G1V 3M7
- 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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Trois-Rivieres, Quebec, Kanada, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 0H6
- 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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Leon, Mexiko, 37000
- 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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Mexico City, Mexiko, 14000
- 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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Monterrey, Mexiko, 64461
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Ponce, Puerto Rico, 00716
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San Juan, Puerto Rico, 00918
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Malmo, Schweden, 21120
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Solna, Schweden, 17176
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Umeå, Schweden, 90185
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Uppsala, Schweden, 75185
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Granada, Spanien, 18012
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Madrid, Spanien, 28046
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Salamanca, Spanien, 37007
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Valencia, Spanien, 46017
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- 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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Montgomery, Alabama, Vereinigte Staaten, 36111
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Arizona
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Peoria, Arizona, Vereinigte Staaten, 85381
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California
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Laguna Hills, California, Vereinigte Staaten, 92653
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Oakland, California, Vereinigte Staaten, 94609
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Connecticut
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Farmington, Connecticut, Vereinigte Staaten, 06030
- 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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Florida
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Palm Harbor, Florida, Vereinigte Staaten, 34684
- 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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Georgia
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Decatur, Georgia, Vereinigte Staaten, 30033
- 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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Gainesville, Georgia, Vereinigte Staaten, 30501
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Illinois
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Morton Grove, Illinois, Vereinigte Staaten, 60053
- 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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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- 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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Iowa
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Urbandale, Iowa, Vereinigte Staaten, 50322
- 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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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68131
- 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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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- 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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Texas
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Houston, Texas, Vereinigte Staaten, 77054
- 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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Washington
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Seattle, Washington, Vereinigte Staaten, 98144
- 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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Spokane, Washington, Vereinigte Staaten, 99204
- 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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West Virginia
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Beckley, West Virginia, Vereinigte Staaten, 25801
- 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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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53705
- 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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Marshfield, Wisconsin, Vereinigte Staaten, 54449
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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
45 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion Criteria:
- Postmenopausal women 45 years or older. No period for at least two years.
- History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
- Minimum of one moderate spinal bone fracture.
- Beginning pain level of at least four on an eleven point scale.
- Bone Mineral Density (BMD) must meet criteria
- Able to read, understand, and administer self-questionnaires.
- Be willing and able to use a pen-injector to deliver the medication.
Exclusion Criteria:
- Are at increased risk for osteosarcoma.
- Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
- Participants that already know that they will require procedures to repair their spinal bone fractures.
- Abnormal values of certain lab tests.
- Anything that would make it difficult to determine if the back pain was due to the fracture.
- Poor medical or psychiatric condition.
- Alcohol or drug abuse within a year of the study start.
- Certain malignant neoplasms in the 5 years prior to enrollment.
- Active liver disease or clinical jaundice.
- Significantly impaired renal function.
- History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
- Known contraindication or intolerance to risedronate and/or teriparatide therapy.
- Treatment with oral strontium or certain therapeutic doses of fluoride.
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 |
---|---|
Experimental: Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
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20 ug/day, subcutaneous, 18 months
Andere Namen:
once weekly, oral, 18 months
Andere Namen:
daily, subcutaneous, 18 months
Andere Namen:
|
Aktiver Komparator: Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
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once weekly, oral, 18 months
Andere Namen:
daily, subcutaneous, 18 months
Andere Namen:
35 mg/once weekly, oral, 18 months
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Zeitfenster: 6 Months
|
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
|
6 Months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Zeitfenster: 12 Months
|
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
|
12 Months
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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Zeitfenster: 6 Months
|
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
|
6 Months
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Zeitfenster: 12 Months
|
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
|
12 Months
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Zeitfenster: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
|
Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months.
Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
|
Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Zeitfenster: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
|
Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months.
Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
|
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Zeitfenster: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
|
Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months.
Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
|
Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Zeitfenster: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
|
Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months.
Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
|
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
|
Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
Zeitfenster: Baseline, 3 Months
|
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain.
The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement.
The number of statements marked are added up by the clinician and a total score is given.
The total score ranges from 0 (no disability) to 24 (severe disability).
|
Baseline, 3 Months
|
Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Zeitfenster: Baseline, 6 Months
|
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain.
The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement.
The number of statements marked are added up by the clinician and a total score is given.
The total score ranges from 0 (no disability) to 24 (severe disability).
|
Baseline, 6 Months
|
Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
Zeitfenster: Baseline, 12 Months
|
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain.
The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement.
The number of statements marked are added up by the clinician and a total score is given.
The total score ranges from 0 (no disability) to 24 (severe disability).
|
Baseline, 12 Months
|
Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Zeitfenster: Baseline, 6 Months
|
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life.
The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function.
The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation.
Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
|
Baseline, 6 Months
|
Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Zeitfenster: Baseline, 12 Months
|
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life.
The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function.
The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation.
Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
|
Baseline, 12 Months
|
Number of Participants With Adverse Events (Safety) During 12 Months
Zeitfenster: Baseline through 12 Months
|
Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
|
Baseline through 12 Months
|
Number of Participants With Adverse Events (Safety) During 18 Months
Zeitfenster: Baseline through 18 Months
|
Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
|
Baseline through 18 Months
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Zeitfenster: 18 Months
|
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
|
18 Months
|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Zeitfenster: 18 Months
|
24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
|
18 Months
|
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
Zeitfenster: Baseline through 18 Months
|
Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months.
Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
|
Baseline through 18 Months
|
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
Zeitfenster: Baseline through 18 Months
|
Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months.
Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit.
The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
|
Baseline through 18 Months
|
Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
Zeitfenster: Baseline, 18 Months
|
Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain.
The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement.
The number of statements marked are added up by the clinician and a total score is given.
The total score ranges from 0 (no disability) to 24 (severe disability).
Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.
|
Baseline, 18 Months
|
Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Zeitfenster: Baseline, 18 Months
|
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life.
The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function.
The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation.
Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
|
Baseline, 18 Months
|
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.
Nützliche Links
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. Juni 2006
Primärer Abschluss (Tatsächlich)
1. Juni 2009
Studienabschluss (Tatsächlich)
1. Juni 2010
Studienanmeldedaten
Zuerst eingereicht
20. Juni 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Juni 2006
Zuerst gepostet (Schätzen)
22. Juni 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
26. Mai 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Mai 2011
Zuletzt verifiziert
1. Mai 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Stoffwechselerkrankungen
- Schmerzen
- Neurologische Manifestationen
- Wunden und Verletzungen
- Erkrankungen des Bewegungsapparates
- Knochenerkrankungen
- Knochenerkrankungen, Stoffwechsel
- Wirbelsäulenverletzungen
- Rückenverletzungen
- Rückenschmerzen
- Frakturen, Knochen
- Osteoporose
- Osteoporose, postmenopausal
- Wirbelsäulenfrakturen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Membrantransportmodulatoren
- Mittel zur Erhaltung der Knochendichte
- Calciumregulierende Hormone und Wirkstoffe
- Kalziumkanalblocker
- Teriparatid
- Risedronsäure
- Etidronsäure
Andere Studien-ID-Nummern
- 9041 (Andere Kennung: CTEP)
- B3D-MC-GHCY (Andere Kennung: Eli Lilly and Company)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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