Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
20 maggio 2011 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
712
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina, C1117ABH
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Malvern East, Australia, 3145
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New South Wales
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Kogarah, New South Wales, Australia, 2217
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Randwick, Sydney, New South Wales, Australia, 2031
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Queensland
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Maroochydore, Queensland, Australia, 4558
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South Australia
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Keswick, South Australia, Australia, 5035
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Brussels, Belgio, 1180
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Gent, Belgio, 9000
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Gozee, Belgio, 6534
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Leuven, Belgio, 3000
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Liege, Belgio, 4000
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Tienen, Belgio, 3300
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Yvoir, Belgio, 5530
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Campinas, Brasile, 13073-350
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Rio De Janeiro, Brasile, 22271-100
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Sao Paulo, Brasile, 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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Amiens, Francia, 80084
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Orleans, Francia, 45000
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Paris, Francia, 75679
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Poitiers, Francia, 86000
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Braunfels, Germania, 35619
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Frankfurt, Germania, 60528
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Hamburg, Germania, 20354
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Heidelberg, Germania, D-69120
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Heinsberg, Germania, 52525
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Leipzig, Germania, 04207
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Marburg, Germania, 35033
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München, Germania, 80335
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Siena, Italia, 53100
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Treviglio, Italia, 24047
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Valeggio Sul Mincio, Italia, 37067
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Leon, Messico, 37000
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Mexico City, Messico, 14000
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Monterrey, Messico, 64461
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Ponce, Porto Rico, 00716
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San Juan, Porto Rico, 00918
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Granada, Spagna, 18012
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Madrid, Spagna, 28046
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Salamanca, Spagna, 37007
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Valencia, Spagna, 46017
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
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Montgomery, Alabama, Stati Uniti, 36111
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Arizona
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Peoria, Arizona, Stati Uniti, 85381
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California
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Laguna Hills, California, Stati Uniti, 92653
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Oakland, California, Stati Uniti, 94609
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06030
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Florida
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Palm Harbor, Florida, Stati Uniti, 34684
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Georgia
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Decatur, Georgia, Stati Uniti, 30033
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Gainesville, Georgia, Stati Uniti, 30501
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Illinois
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Morton Grove, Illinois, Stati Uniti, 60053
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
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Iowa
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Urbandale, Iowa, Stati Uniti, 50322
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68131
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
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Texas
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Houston, Texas, Stati Uniti, 77054
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Washington
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Seattle, Washington, Stati Uniti, 98144
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Spokane, Washington, Stati Uniti, 99204
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West Virginia
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Beckley, West Virginia, Stati Uniti, 25801
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53705
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Marshfield, Wisconsin, Stati Uniti, 54449
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Malmo, Svezia, 21120
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Solna, Svezia, 17176
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Umeå, Svezia, 90185
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Uppsala, Svezia, 75185
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
45 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
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20 ug/day, subcutaneous, 18 months
Altri nomi:
once weekly, oral, 18 months
Altri nomi:
daily, subcutaneous, 18 months
Altri nomi:
|
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Comparatore attivo: Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
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once weekly, oral, 18 months
Altri nomi:
daily, subcutaneous, 18 months
Altri nomi:
35 mg/once weekly, oral, 18 months
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Lasso di tempo: 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
Lasso di tempo: 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
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
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Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
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Number of Participants With Adverse Events (Safety) During 12 Months
Lasso di tempo: 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
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Number of Participants With Adverse Events (Safety) During 18 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2006
Completamento primario (Effettivo)
1 giugno 2009
Completamento dello studio (Effettivo)
1 giugno 2010
Date di iscrizione allo studio
Primo inviato
20 giugno 2006
Primo inviato che soddisfa i criteri di controllo qualità
20 giugno 2006
Primo Inserito (Stima)
22 giugno 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
26 maggio 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 maggio 2011
Ultimo verificato
1 maggio 2011
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie metaboliche
- Dolore
- Manifestazioni neurologiche
- Ferite e lesioni
- Malattie muscoloscheletriche
- Malattie ossee
- Malattie ossee, metaboliche
- Lesioni spinali
- Lesioni alla schiena
- Mal di schiena
- Fratture, ossa
- Osteoporosi
- Osteoporosi, Postmenopausa
- Fratture spinali
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Modulatori di trasporto a membrana
- Agenti di conservazione della densità ossea
- Ormoni e agenti regolatori del calcio
- Bloccanti dei canali del calcio
- Teriparatide
- Acido Risedronico
- Acido Etidronico
Altri numeri di identificazione dello studio
- 9041 (Altro identificatore: CTEP)
- B3D-MC-GHCY (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .