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Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

perjantai 20. toukokuuta 2011 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

712

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Argentiina
      • Buenos Aires, Argentiina, C1117ABH
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  • Australia
      • Malvern East, Australia, 3145
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    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
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      • Randwick, Sydney, New South Wales, Australia, 2031
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    • Queensland
      • Maroochydore, Queensland, Australia, 4558
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    • South Australia
      • Keswick, South Australia, Australia, 5035
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  • Belgia
      • Brussels, Belgia, 1180
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      • Gent, Belgia, 9000
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      • Gozee, Belgia, 6534
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      • Leuven, Belgia, 3000
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      • Liege, Belgia, 4000
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      • Tienen, Belgia, 3300
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      • Yvoir, Belgia, 5530
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  • Brasilia
      • Campinas, Brasilia, 13073-350
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      • Rio De Janeiro, Brasilia, 22271-100
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      • Sao Paulo, Brasilia, 01246-903
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  • Espanja
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      • Madrid, Espanja, 28046
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      • Salamanca, Espanja, 37007
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      • Valencia, Espanja, 46017
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  • Italia
      • Siena, Italia, 53100
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      • Treviglio, Italia, 24047
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      • Valeggio Sul Mincio, Italia, 37067
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  • Kanada
    • British Columbia
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    • Manitoba
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    • Ontario
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      • London, Ontario, Kanada, N6A 4V2
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    • Quebec
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      • Sainte-Foy, Quebec, Kanada, G1V 3M7
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      • Trois-Rivieres, Quebec, Kanada, G8Z 1Y2
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    • Saskatchewan
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  • Meksiko
      • Leon, Meksiko, 37000
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      • Mexico City, Meksiko, 14000
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      • Monterrey, Meksiko, 64461
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  • Puerto Rico
      • Ponce, Puerto Rico, 00716
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      • San Juan, Puerto Rico, 00918
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  • Ranska
      • Amiens, Ranska, 80084
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      • Orleans, Ranska, 45000
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      • Paris, Ranska, 75679
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      • Poitiers, Ranska, 86000
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  • Ruotsi
      • Malmo, Ruotsi, 21120
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      • Solna, Ruotsi, 17176
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      • Umeå, Ruotsi, 90185
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      • Uppsala, Ruotsi, 75185
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  • Saksa
      • Braunfels, Saksa, 35619
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      • Frankfurt, Saksa, 60528
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      • Hamburg, Saksa, 20354
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      • Heidelberg, Saksa, D-69120
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      • Heinsberg, Saksa, 52525
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      • Leipzig, Saksa, 04207
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      • Marburg, Saksa, 35033
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      • München, Saksa, 80335
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  • Yhdysvallat
    • Alabama
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      • Montgomery, Alabama, Yhdysvallat, 36111
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    • Arizona
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    • California
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      • Oakland, California, Yhdysvallat, 94609
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    • Connecticut
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    • Florida
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    • Georgia
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      • Gainesville, Georgia, Yhdysvallat, 30501
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    • Illinois
      • Morton Grove, Illinois, Yhdysvallat, 60053
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    • Indiana
      • Indianapolis, Indiana, Yhdysvallat, 46202
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    • Iowa
      • Urbandale, Iowa, Yhdysvallat, 50322
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    • Nebraska
      • Omaha, Nebraska, Yhdysvallat, 68131
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    • Ohio
      • Cleveland, Ohio, Yhdysvallat, 44195
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    • Texas
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    • Washington
      • Seattle, Washington, Yhdysvallat, 98144
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      • Spokane, Washington, Yhdysvallat, 99204
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    • West Virginia
      • Beckley, West Virginia, Yhdysvallat, 25801
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    • Wisconsin
      • Madison, Wisconsin, Yhdysvallat, 53705
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      • Marshfield, Wisconsin, Yhdysvallat, 54449
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Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

45 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Nainen

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Lääke: teriparatide
20 ug/day, subcutaneous, 18 months
Muut nimet:
  • Forteo
  • LY333334
  • Forsteo
Lääke: placebo
once weekly, oral, 18 months
Muut nimet:
  • Forteo
  • LY333334
  • Forsteo
Lääke: placebo
daily, subcutaneous, 18 months
Muut nimet:
  • Actonel
Active Comparator: Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Lääke: placebo
once weekly, oral, 18 months
Muut nimet:
  • Forteo
  • LY333334
  • Forsteo
Lääke: placebo
daily, subcutaneous, 18 months
Muut nimet:
  • Actonel
Lääke: risedronate
35 mg/once weekly, oral, 18 months
Muut nimet:
  • Actonel

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Aikaikkuna: 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
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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)
Aikaikkuna: 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

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Torstai 1. kesäkuuta 2006

Ensisijainen valmistuminen (Todellinen)

Maanantai 1. kesäkuuta 2009

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Torstai 26. toukokuuta 2011

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  • 9041 (Muu tunniste: CTEP)
  • B3D-MC-GHCY (Muu tunniste: Eli Lilly and Company)

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