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

Condition(s) targeted: Osteoporosis, Postmenopausal; Back Pain; Spinal Fracture

Intervention: teriparatide (Drug); risedronate (Drug); placebo (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

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.

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Lilly Clinical Trial Registry

Starting date: June 2006
Last updated: May 20, 2011