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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-MC-GHCY | Other Identifier | Eli Lilly and Company |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo |
|
| Risedronate | Active Comparator | Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | 20 ug/day, subcutaneous, 18 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Birmingham | Alabama | 35294 |
712 participants were randomized: 361 to teriparatide; 351 to risedronate. 2 participants did not receive drug. Only randomized participants who received at least 1 dose of drug were analyzed. At 18 months, reason for discontinuation was corrected from sponsor decision to entry criteria not met (1) and protocol violation (1) for 2 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo |
| FG001 | Risedronate | Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| All Randomized Participants |
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| risedronate | Drug | 35 mg/once weekly, oral, 18 months |
|
|
| placebo | Drug | once weekly, oral, 18 months |
|
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| placebo | Drug | daily, subcutaneous, 18 months |
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| 12 Months |
| Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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) | 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 |
| United States |
| 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. | Montgomery | Alabama | 36111 | United States |
| 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. | Peoria | Arizona | 85381 | United States |
| 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. | Laguna Hills | California | 92653 | United States |
| 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. | Oakland | California | 94609 | United States |
| 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. | Farmington | Connecticut | 06030 | United States |
| 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. | Palm Harbor | Florida | 34684 | United States |
| 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. | Decatur | Georgia | 30033 | United States |
| 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. | Gainesville | Georgia | 30501 | United States |
| 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. | Morton Grove | Illinois | 60053 | United States |
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| 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. | Marburg | 35033 | Germany |
| 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. | München | 80335 | Germany |
| 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. | Siena | 53100 | Italy |
| 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. | Treviglio | 24047 | Italy |
| 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. | Valeggio sul Mincio | 37067 | Italy |
| 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. | León | 37000 | Mexico |
| 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. | Mexico City | 14000 | Mexico |
| 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. | Monterrey | 64461 | Mexico |
| 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. | Ponce | 00716 | Puerto Rico |
| 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. | San Juan | 00918 | Puerto Rico |
| 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. | Granada | 18012 | Spain |
| 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. | Madrid | 28046 | Spain |
| 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. | Salamanca | 37007 | Spain |
| 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. | Valencia | 46017 | Spain |
| 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. | Malmö | 21120 | Sweden |
| 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. | Solna | 17176 | Sweden |
| 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. | Umeå | 90185 | Sweden |
| 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. | Uppsala | 75185 | Sweden |
| COMPLETED |
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| NOT COMPLETED |
|
| 6 Months (All Treated Participants) |
|
|
| 12 Months (All Treated Participants) |
|
|
| 18 Months (All Treated Participants) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo |
| BG001 | Risedronate | Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Number of Vertebral Fractures | A minimum of at least one moderate osteoporotic vertebral fracture was radiologically detected and vertebral fracture status was documented. A moderate vertebral fracture was defined as at least a 25% decrease in anterior, central, or posterior vertebral height (T4 to L4) as compared to the average height of adjacent vertebrae. This measure categorizes the number of vertebral fractures for each participant. | Number | participants |
| |||||||||||||||
| Prior Osteoporosis Drug Use | Participants answered yes or no regarding use of osteoporosis drugs prior to this study. | Number | participants |
| |||||||||||||||
| Severity of Vertebral Fracture | An experienced radiologist graded all vertebrae by visual inspection from normal (grade 0) to severely deformed (grade 3). | Number | participants |
| |||||||||||||||
| Spinal Deformity Index | Spinal deformity index is the summation of the severity of the vertebral fracture(s). | Number | units on a scale |
| |||||||||||||||
| 24-Hour Average Back Pain Score | 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 specified last observation carried forward (LOCF) endpoint. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 24-Hour Worst Back Pain Score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/meters squared |
| ||||||||||||||
| Duration of Back Pain | Mean | Standard Deviation | days |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Roland-Morris Disability Questionnaire Score | 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 is added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | 6 Months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | 12 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | 12 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days. | Posted | Number | participants | Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. | Posted | Number | participants | Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. | 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). | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 3 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. | 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). | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 6 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. | 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). | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 6 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | 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. | Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (Safety) During 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. | Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate. | Posted | Number | participants | Baseline through 12 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (Safety) During 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. | Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate. | Posted | Number | participants | Baseline through 18 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint | 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. | Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug. | Posted | Jun 2011 | Number | participants | 18 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint | 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. | Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug. | Posted | Jun 2011 | Number | participants | 18 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 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. | Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time. | Posted | Jun 2011 | Number | participants | Baseline through 18 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 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. | Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time. | Posted | Jun 2011 | Number | participants | Baseline through 18 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. | 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. | Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug. | Posted | Jun 2011 | Least Squares Mean | Standard Error | units on a scale | Baseline, 18 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) | 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. | Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug. | Posted | Jun 2011 | Least Squares Mean | Standard Error | units on a scale | Baseline, 18 Months |
|
|
Baseline to 18 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide | Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo | 55 | 360 | 277 | 360 | ||
| EG001 | Risedronate | Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo | 66 | 350 | 273 | 350 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oscillopsia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Blister infected | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Vaginal abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome transformation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperreflexia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Activities of daily living impaired | Social circumstances | MedDRA 13.0 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Vertebroplasty | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D001416 | Back Pain |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Entry Criteria Not Met |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| Entry Criteria Not Met |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| Entry Criteria Not Met |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| Male |
|
| African Descent |
|
| Caucasian |
|
| East Asian |
|
| Native American |
|
| Argentina |
|
| Australia |
|
| Belgium |
|
| Brazil |
|
| Canada |
|
| France |
|
| Italy |
|
| Mexico |
|
| Puerto Rico |
|
| Spain |
|
| Sweden |
|
| Germany |
|
| 1 Vertebral Fracture |
|
| >=2 Vertebral Fractures |
|
| No |
|
| Moderate Severity (Grade 2) |
|
| Severe (Grade 3) |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| >=3 |
|
| Unknown or Not Reported |
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|