- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00343252
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
20 mai 2011 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
712
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Braunfels, Allemagne, 35619
- 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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Frankfurt, Allemagne, 60528
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Hamburg, Allemagne, 20354
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Heidelberg, Allemagne, D-69120
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Heinsberg, Allemagne, 52525
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Leipzig, Allemagne, 04207
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Marburg, Allemagne, 35033
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München, Allemagne, 80335
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Buenos Aires, Argentine, C1117ABH
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Malvern East, Australie, 3145
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New South Wales
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Kogarah, New South Wales, Australie, 2217
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Randwick, Sydney, New South Wales, Australie, 2031
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Queensland
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Maroochydore, Queensland, Australie, 4558
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South Australia
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Keswick, South Australia, Australie, 5035
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Brussels, Belgique, 1180
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Gent, Belgique, 9000
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Gozee, Belgique, 6534
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Leuven, Belgique, 3000
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Liege, Belgique, 4000
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Tienen, Belgique, 3300
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Yvoir, Belgique, 5530
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Campinas, Brésil, 13073-350
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Rio De Janeiro, Brésil, 22271-100
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Sao Paulo, Brésil, 01246-903
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3X8
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M3
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Ontario
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Hamilton, Ontario, Canada, L8N 1Y2
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London, Ontario, Canada, N6A 4V2
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Sainte-Foy, Quebec, Canada, G1V 3M7
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
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Granada, Espagne, 18012
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Madrid, Espagne, 28046
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Salamanca, Espagne, 37007
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Valencia, Espagne, 46017
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Amiens, France, 80084
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Orleans, France, 45000
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Paris, France, 75679
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Poitiers, France, 86000
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Siena, Italie, 53100
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Treviglio, Italie, 24047
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Valeggio Sul Mincio, Italie, 37067
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Leon, Mexique, 37000
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Mexico City, Mexique, 14000
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Monterrey, Mexique, 64461
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Ponce, Porto Rico, 00716
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San Juan, Porto Rico, 00918
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Malmo, Suède, 21120
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Solna, Suède, 17176
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Umeå, Suède, 90185
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Uppsala, Suède, 75185
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Alabama
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Birmingham, Alabama, États-Unis, 35294
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Montgomery, Alabama, États-Unis, 36111
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Arizona
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Peoria, Arizona, États-Unis, 85381
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California
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Laguna Hills, California, États-Unis, 92653
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Oakland, California, États-Unis, 94609
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Connecticut
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Farmington, Connecticut, États-Unis, 06030
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Florida
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Palm Harbor, Florida, États-Unis, 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, États-Unis, 30033
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Gainesville, Georgia, États-Unis, 30501
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Illinois
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Morton Grove, Illinois, États-Unis, 60053
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
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Iowa
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Urbandale, Iowa, États-Unis, 50322
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Nebraska
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Omaha, Nebraska, États-Unis, 68131
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Ohio
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Cleveland, Ohio, États-Unis, 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, États-Unis, 77054
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Washington
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Seattle, Washington, États-Unis, 98144
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Spokane, Washington, États-Unis, 99204
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West Virginia
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Beckley, West Virginia, États-Unis, 25801
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Wisconsin
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Madison, Wisconsin, États-Unis, 53705
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Marshfield, Wisconsin, États-Unis, 54449
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
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20 ug/day, subcutaneous, 18 months
Autres noms:
once weekly, oral, 18 months
Autres noms:
daily, subcutaneous, 18 months
Autres noms:
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Comparateur actif: Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
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once weekly, oral, 18 months
Autres noms:
daily, subcutaneous, 18 months
Autres noms:
35 mg/once weekly, oral, 18 months
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Délai: 6 Months
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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.
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6 Months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Délai: 12 Months
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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.
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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
Délai: 6 Months
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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.
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6 Months
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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
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Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2006
Achèvement primaire (Réel)
1 juin 2009
Achèvement de l'étude (Réel)
1 juin 2010
Dates d'inscription aux études
Première soumission
20 juin 2006
Première soumission répondant aux critères de contrôle qualité
20 juin 2006
Première publication (Estimation)
22 juin 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 mai 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2011
Dernière vérification
1 mai 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies métaboliques
- La douleur
- Manifestations neurologiques
- Blessures et Blessures
- Maladies musculo-squelettiques
- Maladies osseuses
- Maladies osseuses métaboliques
- Blessures à la colonne vertébrale
- Blessures au dos
- Mal au dos
- Fractures, Os
- Ostéoporose
- Ostéoporose, Postménopause
- Fractures de la colonne vertébrale
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Modulateurs de transport membranaire
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Bloqueurs de canaux calciques
- Tériparatide
- Acide risédronique
- Acide étidronique
Autres numéros d'identification d'étude
- 9041 (Autre identifiant: CTEP)
- B3D-MC-GHCY (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Mal au dos
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Evergrain, LLCINQUIS Clinical Research Ltd.ComplétéSatiété du pain riche en fibres et riche en protéinesCanada
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Tel-Aviv Sourasky Medical CenterWeizmann Institute of ScienceComplétéChangements de poids corporel | Modification alimentaire | Microbiote gastro-intestinal | Pain | Tests hématologiquesIsraël
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University of BergenUniversity of Leipzig; Chalmers University of Technology; Nofima; Paderborn UniversityComplétéHyperglycémie | Prédiabète | Contrôle glycémique | PainNorvège
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Ege UniversityComplétéObésité | Index glycémique | Glucose sanguin | PainTurquie
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)ComplétéEfficacité et Tolérance de B-Back® sur le Syndrome de BurnoutFrance
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Herlev HospitalComplétéLa cardiopathie ischémique | Biofeed Back Gestion du stress guidéeDanemark