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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
Country [18] 0 0
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
Country [27] 0 0
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
Country [32] 0 0
France
State/province [32] 0 0
Amiens
Country [33] 0 0
France
State/province [33] 0 0
Orleans
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Poitiers
Country [36] 0 0
Germany
State/province [36] 0 0
Braunfels
Country [37] 0 0
Germany
State/province [37] 0 0
Frankfurt
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
Country [39] 0 0
Germany
State/province [39] 0 0
Heidelberg
Country [40] 0 0
Germany
State/province [40] 0 0
Heinsberg
Country [41] 0 0
Germany
State/province [41] 0 0
Leipzig
Country [42] 0 0
Germany
State/province [42] 0 0
Marburg
Country [43] 0 0
Germany
State/province [43] 0 0
München
Country [44] 0 0
Italy
State/province [44] 0 0
Siena
Country [45] 0 0
Italy
State/province [45] 0 0
Treviglio
Country [46] 0 0
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
State/province [48] 0 0
Mexico City
Country [49] 0 0
Mexico
State/province [49] 0 0
Monterrey
Country [50] 0 0
Puerto Rico
State/province [50] 0 0
Ponce
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
San Juan
Country [52] 0 0
Spain
State/province [52] 0 0
Granada
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Salamanca
Country [55] 0 0
Spain
State/province [55] 0 0
Valencia
Country [56] 0 0
Sweden
State/province [56] 0 0
Malmo
Country [57] 0 0
Sweden
State/province [57] 0 0
Solna
Country [58] 0 0
Sweden
State/province [58] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00343252