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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00343252
Registration number
NCT00343252
Ethics application status
Date submitted
20/06/2006
Date registered
22/06/2006
Date last updated
26/05/2011
Titles & IDs
Public title
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
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Scientific title
The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures
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Secondary ID [1]
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B3D-MC-GHCY
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Secondary ID [2]
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9041
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal
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Back Pain
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Spinal Fracture
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Condition category
Condition code
Musculoskeletal
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0
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0
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Osteoporosis
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Reproductive Health and Childbirth
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0
0
0
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Menstruation and menopause
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Musculoskeletal
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0
0
0
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Other muscular and skeletal disorders
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Neurological
0
0
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0
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Other neurological disorders
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Injuries and Accidents
0
0
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0
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Fractures
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - teriparatide
Treatment: Drugs - risedronate
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Experimental: Teriparatide - Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Active Comparator: Risedronate - Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Treatment: Drugs: teriparatide
20 ug/day, subcutaneous, 18 months
Treatment: Drugs: risedronate
35 mg/once weekly, oral, 18 months
Treatment: Drugs: placebo
once weekly, oral, 18 months
Treatment: Drugs: placebo
daily, subcutaneous, 18 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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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Timepoint [1]
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6 Months
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Secondary outcome [1]
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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
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Assessment method [1]
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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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Timepoint [1]
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12 Months
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Secondary outcome [2]
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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
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Assessment method [2]
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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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Timepoint [2]
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6 Months
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Secondary outcome [3]
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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
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Assessment method [3]
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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 12-month last observation carried forward (LOCF) endpoint.
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Timepoint [3]
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12 Months
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Secondary outcome [4]
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Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
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Assessment method [4]
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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.
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Timepoint [4]
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Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
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Secondary outcome [5]
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Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
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Assessment method [5]
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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.
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Timepoint [5]
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0
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
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Secondary outcome [6]
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Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
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Assessment method [6]
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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.
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Timepoint [6]
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0
Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
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Secondary outcome [7]
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Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
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Assessment method [7]
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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.
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Timepoint [7]
0
0
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
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Secondary outcome [8]
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Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline, 3 Months
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Secondary outcome [9]
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Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
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Assessment method [9]
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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).
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Timepoint [9]
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Baseline, 6 Months
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Secondary outcome [10]
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Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
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Assessment method [10]
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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).
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Timepoint [10]
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Baseline, 12 Months
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Secondary outcome [11]
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Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, 6 Months
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Secondary outcome [12]
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Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
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Assessment method [12]
0
0
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.
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Timepoint [12]
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Baseline, 12 Months
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Secondary outcome [13]
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Number of Participants With Adverse Events (Safety) During 12 Months
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline through 12 Months
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Secondary outcome [14]
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Number of Participants With Adverse Events (Safety) During 18 Months
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Assessment method [14]
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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.
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Timepoint [14]
0
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Baseline through 18 Months
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Secondary outcome [15]
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0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
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Assessment method [15]
0
0
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.
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Timepoint [15]
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0
18 Months
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Secondary outcome [16]
0
0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
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Assessment method [16]
0
0
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.
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Timepoint [16]
0
0
18 Months
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Secondary outcome [17]
0
0
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
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Assessment method [17]
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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.
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Timepoint [17]
0
0
Baseline through 18 Months
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Secondary outcome [18]
0
0
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
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Assessment method [18]
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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.
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Timepoint [18]
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0
Baseline through 18 Months
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Secondary outcome [19]
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Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
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Assessment method [19]
0
0
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.
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Timepoint [19]
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0
Baseline, 18 Months
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Secondary outcome [20]
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Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
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Assessment method [20]
0
0
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.
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Timepoint [20]
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Baseline, 18 Months
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Eligibility
Key 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.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
712
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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0
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. - Kogarah
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Recruitment hospital [2]
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0
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. - Randwick, Sydney
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Recruitment hospital [3]
0
0
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. - Maroochydore
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Recruitment hospital [4]
0
0
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. - Keswick
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Recruitment hospital [5]
0
0
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. - Malvern East
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Recruitment postcode(s) [1]
0
0
2217 - Kogarah
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Recruitment postcode(s) [2]
0
0
2031 - Randwick, Sydney
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Recruitment postcode(s) [3]
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0
4558 - Maroochydore
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Recruitment postcode(s) [4]
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0
5035 - Keswick
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Recruitment postcode(s) [5]
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0
3145 - Malvern East
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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0
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United States of America
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Arizona
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0
United States of America
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California
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0
United States of America
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Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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0
0
United States of America
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Indiana
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0
United States of America
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Iowa
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0
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Nebraska
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0
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Ohio
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0
0
United States of America
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Texas
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0
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Washington
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West Virginia
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Wisconsin
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0
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Argentina
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Buenos Aires
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Gozee
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Belgium
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Leuven
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0
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Belgium
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Liege
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Belgium
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Tienen
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Belgium
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Yvoir
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Brazil
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Campinas
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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France
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Amiens
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France
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Orleans
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France
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Paris
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France
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Poitiers
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Germany
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Braunfels
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Heinsberg
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Germany
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Leipzig
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Germany
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Marburg
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Germany
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0
0
München
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Italy
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Siena
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Italy
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Treviglio
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Italy
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Valeggio Sul Mincio
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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Monterrey
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Ponce
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San Juan
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Granada
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Malmo
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Sweden
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Solna
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Sweden
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Umeå
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Sweden
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00343252
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00343252
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