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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00343252
First received: June 20, 2006
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Back Pain
Spinal Fracture
Drug: teriparatide
Drug: risedronate
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    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 Participants With Adverse Events (Safety) During 12 Months [ Time Frame: Baseline through 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Adverse Events (Safety) During 18 Months [ Time Frame: Baseline through 18 Months ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 18 Months ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [ Time Frame: Baseline, 18 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 712
Study Start Date: June 2006
Study Completion Date: June 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Drug: teriparatide
20 ug/day, subcutaneous, 18 months
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Drug: placebo
once weekly, oral, 18 months
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Active Comparator: Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Drug: risedronate
35 mg/once weekly, oral, 18 months
Other Name: Actonel
Drug: placebo
daily, subcutaneous, 18 months
Other Name: Actonel

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343252

  Show 72 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00343252     History of Changes
Other Study ID Numbers: 9041, B3D-MC-GHCY
Study First Received: June 20, 2006
Results First Received: June 8, 2010
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Fractures, Bone
Osteoporosis
Osteoporosis, Postmenopausal
Spinal Fractures
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Risedronic acid
Etidronic Acid
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014