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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid; Teriparatide

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.