Official Title: “The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures”

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in postmenopausal women with osteoporosis that have back pain due to a spinal bone fracture.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: teriparatide
  • 20 micrograms/day, subcutaneous, 18 months
• Drug: risedronate
  • 35mg/once weekly, oral, 18 months
• Drug: placebo
  • 35mg/once weekly, oral, 18 months
• Drug: placebo
  • 20 micrograms/day, subcutaneous, 18 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Teriparatide 20 micrograms/day, subcutaneous, 18 months plus once weekly oral placebo
• Active Comparator: B
  • Risedronate 35mg/once weekly, oral, 18 months plus daily injection placebo

Primary Measures

• Comparison of teriparatide versus risedronate on the reduction of back pain related to spinal bone fractures in osteoporotic postmenopausal women.
  • Time Frame: Baseline to 6 months
    Safety Issue?: No

Secondary Measures

• 11 point pain scale, severity of worst back pain, 30% reduction
  • Time Frame: Baseline to 12 and 18 months
    Safety Issue?: No
• 11 point pain scale, severity of average back pain, 30% reduction
  • Time Frame: Baseline to 6, 12, and 18 months
    Safety Issue?: No
• Time to first occurrence, 30% reduction for worst back pain using mean score from 11 point pain scale
  • Time Frame: Baseline to 6, 12, and 18 months
    Safety Issue?: No
• Roland Disability Questionnaire.
  • Time Frame: Baseline to 3, 6, 12, and 18 months
    Safety Issue?: No
• QUALEFFO quality of life questionnaire
  • Time Frame: Baseline to 6, 12, and 18 months
    Safety Issue?: No
• Time to first occurrence, 30% reduction for average back pain using mean score from 11 point pain scale
  • Time Frame: Baseline to 6, 12, and 18 months
    Safety Issue?: No
• Safety
  • Time Frame: Baseline to 18 months
    Safety Issue?: Yes

Inclusion Criteria:

• Postmenopausal women 45 years or older. No period for at least two years.
• History of back pain (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.
• Patients 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00343252

Study ID Number: 9041

ClinicalTrials.gov Identifier: NCT00343252

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry