Clinical trial NCT00343252: Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
Official title: The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Back Pain
Spinal Fracture
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 712
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
timeFrame: 12 Months
measure: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
timeFrame: 6 Months
measure: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
timeFrame: 12 Months
measure: Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
timeFrame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
measure: Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
timeFrame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
measure: Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
timeFrame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
measure: Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
timeFrame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
measure: Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
timeFrame: Baseline, 3 Months
measure: Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
timeFrame: Baseline, 6 Months
measure: Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
timeFrame: Baseline, 12 Months
measure: Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
timeFrame: Baseline, 6 Months
measure: Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
timeFrame: Baseline, 12 Months
measure: Number of Participants With Adverse Events (Safety) During 12 Months
timeFrame: Baseline through 12 Months
measure: Number of Participants With Adverse Events (Safety) During 18 Months
timeFrame: Baseline through 18 Months
measure: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
timeFrame: 18 Months
measure: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
timeFrame: 18 Months
measure: Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
timeFrame: Baseline through 18 Months
measure: Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
timeFrame: Baseline through 18 Months
measure: Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
timeFrame: Baseline, 18 Months
measure: Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
timeFrame: Baseline, 18 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alabama
city: Montgomery
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alabama
city: Peoria
country: United States
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state: Arizona
city: Laguna Hills
country: United States
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state: California
city: Oakland
country: United States
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state: California
city: Farmington
country: United States
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state: Connecticut
city: Palm Harbor
country: United States
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state: Florida
city: Decatur
country: United States
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state: Georgia
city: Gainesville
country: United States
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state: Georgia
city: Morton Grove
country: United States
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state: Illinois
city: Indianapolis
country: United States
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state: Indiana
city: Urbandale
country: United States
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state: Iowa
city: Omaha
country: United States
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state: Nebraska
city: Cleveland
country: United States
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state: Ohio
city: Houston
country: United States
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state: Texas
city: Seattle
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Beckley
country: United States
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state: West Virginia
city: Madison
country: United States
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state: Wisconsin
city: Marshfield
country: United States
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Kogarah
country: Australia
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state: New South Wales
city: Randwick, Sydney
country: Australia
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state: New South Wales
city: Maroochydore
country: Australia
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state: Queensland
city: Keswick
country: Australia
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state: South Australia
city: Malvern East
country: Australia
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city: Brussels
country: Belgium
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city: Gent
country: Belgium
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city: Gozee
country: Belgium
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city: Leuven
country: Belgium
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city: Liege
country: Belgium
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city: Tienen
country: Belgium
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city: Yvoir
country: Belgium
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city: Campinas
country: Brazil
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city: Rio De Janeiro
country: Brazil
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city: Sao Paulo
country: Brazil
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city: Vancouver
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Hamilton
country: Canada
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state: Ontario
city: London
country: Canada
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state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Sainte-Foy
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Quebec
city: Trois-Rivieres
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Quebec
city: Saskatoon
country: Canada
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state: Saskatchewan
city: Amiens
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Orleans
country: France
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city: Paris
country: France
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city: Poitiers
country: France
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city: Braunfels
country: Germany
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city: Frankfurt
country: Germany
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city: Hamburg
country: Germany
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city: Heidelberg
country: Germany
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city: Heinsberg
country: Germany
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city: Leipzig
country: Germany
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city: Marburg
country: Germany
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city: München
country: Germany
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city: Siena
country: Italy
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city: Treviglio
country: Italy
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city: Valeggio Sul Mincio
country: Italy
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city: Leon
country: Mexico
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city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
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city: Ponce
country: Puerto Rico
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city: San Juan
country: Puerto Rico
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city: Granada
country: Spain
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city: Madrid
country: Spain
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city: Salamanca
country: Spain
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city: Valencia
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malmo
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Solna
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Umeå
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Uppsala
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: