Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) 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 - 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) 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 - 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) 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 - 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) 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 - Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
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 - Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
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 - Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
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 - Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
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. - Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
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. - Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
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. - Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
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) - QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
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) - QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Timepoint [12] 0 0
Baseline, 12 Months
Secondary outcome [13] 0 0
Number of Participants With Adverse Events (Safety) During 12 Months - Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Timepoint [13] 0 0
Baseline through 12 Months
Secondary outcome [14] 0 0
Number of Participants With Adverse Events (Safety) During 18 Months - Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
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 - 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) 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 - 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) 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 - Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
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 - Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
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. - Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.
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) - QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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/show/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
Other publications