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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00343252 (opens ClinicalTrials.gov in a new tab)Other id9041Other idB3D-MC-GHCY
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
712 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
13 countries

United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain, Sweden

Start
Jun 2006
Primary completion
Jun 2009
Completion
Jun 2010
First posted
22 Jun 2006 (estimated)
Last update posted
26 May 2011 (estimated)
Conditions
Osteoporosis, Postmenopausal · Back Pain · Spinal Fracture

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 3

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

    NCT00343252

    Jun 2006 to Jun 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • teriparatideDrug
  • risedronateDrug
  • placeboDrug
  • placeboDrug

Arms2

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint

    Time frame · 6 Months

    Registry description

    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.

Secondary outcomes(20)

  1. Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

    Time frame · 12 Months

    Registry description

    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.

  2. Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

    Time frame · 6 Months

    Registry description

    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.

  3. Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

    Time frame · 12 Months

    Registry description

    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.

  4. Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months

    Time frame · Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

    Registry description

    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.

  5. Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

    Time frame · Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

    Registry description

    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.

  6. 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 frame · Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

    Registry description

    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.

  7. 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 frame · Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

    Registry description

    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.

  8. Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.

    Time frame · Baseline, 3 Months

    Registry description

    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).

  9. Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.

    Time frame · Baseline, 6 Months

    Registry description

    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).

  10. Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.

    Time frame · Baseline, 12 Months

    Registry description

    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).

  11. Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

    Time frame · Baseline, 6 Months

    Registry description

    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.

  12. Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

    Time frame · Baseline, 12 Months

    Registry description

    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.

  13. Number of Participants With Adverse Events (Safety) During 12 Months

    Time frame · Baseline through 12 Months

    Registry description

    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.

  14. Number of Participants With Adverse Events (Safety) During 18 Months

    Time frame · Baseline through 18 Months

    Registry description

    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.

  15. Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint

    Time frame · 18 Months

    Registry description

    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.

  16. Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint

    Time frame · 18 Months

    Registry description

    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.

  17. Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months

    Time frame · Baseline through 18 Months

    Registry description

    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.

  18. 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 frame · Baseline through 18 Months

    Registry description

    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.

  19. Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.

    Time frame · Baseline, 18 Months

    Registry description

    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.

  20. Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

    Time frame · Baseline, 18 Months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 Months

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

GroupValue (participants)
Teriparatide206
Risedronate193
Secondary and other outcome results(7)
Secondary outcomeNumber· 12 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

GroupValue (participants)
Teriparatide233
Risedronate220
Secondary outcomeNumber· 6 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

GroupValue (participants)
Teriparatide221
Risedronate211
Secondary outcomeNumber· 12 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

GroupValue (participants)
Teriparatide246
Risedronate238
Secondary outcomeNumber· 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 6 Months

GroupValue (participants)
Teriparatide0
Risedronate0
Secondary outcomeNumber· Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

GroupValue (participants)
Teriparatide0
Risedronate0
Secondary outcomeNumber· 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 6 Months

GroupValue (participants)
Teriparatide0
Risedronate0
Secondary outcomeNumber· 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 12 Months

GroupValue (participants)
Teriparatide0
Risedronate0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideTeriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo–55 / 360277 / 360
RisedronateRisedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo–66 / 350273 / 350

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Postmenopausal women 45 years or older. No period for at least two years. * History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator). * Minimum of one moderate spinal bone fracture. * Beginning pain level of at least four on an eleven point scale. * Bone Mineral Density (BMD) must meet criteria * Able to read, understand, and administer self-questionnaires. * Be willing and able to use a pen-injector to deliver the medication. Exclusion Criteria: * Are at increased risk for osteosarcoma. * Have an active or suspected diseases that affects bone metabolism other than osteoporosis. * Participants that already know that they will require procedures to repair their spinal bone fractures. * Abnormal values of certain lab tests. * Anything that would make it difficult to determine if the back pain was due to the fracture. * Poor medical or psychiatric condition. * Alcohol or drug abuse within a year of the study start. * Certain malignant neoplasms in the 5 years prior to enrollment. * Active liver disease or clinical jaundice. * Significantly impaired renal function. * History of nephrolithiasis or urolithiasis within 2 years prior to enrollment. * Known contraindication or intolerance to risedronate and/or teriparatide therapy. * Treatment with oral strontium or certain therapeutic doses of fluoride.

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