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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00343252




Registration number
NCT00343252
Ethics application status
Date submitted
20/06/2006
Date registered
22/06/2006
Date last updated
26/05/2011

Titles & IDs
Public title
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
Scientific title
The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures
Secondary ID [1] 0 0
B3D-MC-GHCY
Secondary ID [2] 0 0
9041
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal 0 0
Back Pain 0 0
Spinal Fracture 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - teriparatide
Treatment: Drugs - risedronate
Treatment: Drugs - placebo
Treatment: Drugs - placebo

Experimental: Teriparatide - Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo

Active comparator: Risedronate - Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo


Treatment: Drugs: teriparatide
20 ug/day, subcutaneous, 18 months

Treatment: Drugs: risedronate
35 mg/once weekly, oral, 18 months

Treatment: Drugs: placebo
once weekly, oral, 18 months

Treatment: Drugs: placebo
daily, subcutaneous, 18 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Timepoint [4] 0 0
Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Secondary outcome [5] 0 0
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Timepoint [5] 0 0
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Secondary outcome [6] 0 0
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Timepoint [6] 0 0
Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Secondary outcome [7] 0 0
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Timepoint [7] 0 0
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Secondary outcome [8] 0 0
Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
Timepoint [8] 0 0
Baseline, 3 Months
Secondary outcome [9] 0 0
Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Timepoint [9] 0 0
Baseline, 6 Months
Secondary outcome [10] 0 0
Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
Timepoint [10] 0 0
Baseline, 12 Months
Secondary outcome [11] 0 0
Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Timepoint [11] 0 0
Baseline, 6 Months
Secondary outcome [12] 0 0
Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Timepoint [12] 0 0
Baseline, 12 Months
Secondary outcome [13] 0 0
Number of Participants With Adverse Events (Safety) During 12 Months
Timepoint [13] 0 0
Baseline through 12 Months
Secondary outcome [14] 0 0
Number of Participants With Adverse Events (Safety) During 18 Months
Timepoint [14] 0 0
Baseline through 18 Months
Secondary outcome [15] 0 0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Timepoint [15] 0 0
18 Months
Secondary outcome [16] 0 0
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Timepoint [16] 0 0
18 Months
Secondary outcome [17] 0 0
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
Timepoint [17] 0 0
Baseline through 18 Months
Secondary outcome [18] 0 0
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
Timepoint [18] 0 0
Baseline through 18 Months
Secondary outcome [19] 0 0
Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
Timepoint [19] 0 0
Baseline, 18 Months
Secondary outcome [20] 0 0
Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Timepoint [20] 0 0
Baseline, 18 Months

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
712
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
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. - Kogarah
Recruitment hospital [2] 0 0
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. - Randwick, Sydney
Recruitment hospital [3] 0 0
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. - Maroochydore
Recruitment hospital [4] 0 0
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. - Keswick
Recruitment hospital [5] 0 0
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. - Malvern East
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Randwick, Sydney
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
United States of America
State/province [14] 0 0
West Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussels
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Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Gozee
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Belgium
State/province [21] 0 0
Liege
Country [22] 0 0
Belgium
State/province [22] 0 0
Tienen
Country [23] 0 0
Belgium
State/province [23] 0 0
Yvoir
Country [24] 0 0
Brazil
State/province [24] 0 0
Campinas
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio De Janeiro
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
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Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Manitoba
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
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France
State/province [32] 0 0
Amiens
Country [33] 0 0
France
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Orleans
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France
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Paris
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France
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Poitiers
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Germany
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Braunfels
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Heinsberg
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Germany
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Leipzig
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Germany
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Marburg
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Germany
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München
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Italy
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Siena
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Italy
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Treviglio
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Italy
State/province [46] 0 0
Valeggio Sul Mincio
Country [47] 0 0
Mexico
State/province [47] 0 0
Leon
Country [48] 0 0
Mexico
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Mexico City
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Mexico
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Monterrey
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Puerto Rico
State/province [50] 0 0
Ponce
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Puerto Rico
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San Juan
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Spain
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Granada
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Malmo
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Sweden
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Solna
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Sweden
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Umeå
Country [59] 0 0
Sweden
State/province [59] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00343252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00343252