Osteoporosis, PostmenopausalPhase 3NCT00343252

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

A Phase 3 study testing teriparatide and risedronate in people with Osteoporosis, Postmenopausal and Back Pain, run by Eli Lilly and Company at 72 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 years and older, women only
Conditions the study is for: Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture
What is being tested?: teriparatide and risedronate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 712 participants
Where: 72 sitesin 13 countries
Study dates: Jun 2006to Jun 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

72 sites in 13 countries.

Country

City, postcode or hospital

72 sites in 13 countries

United States20 sites

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Beckley, West Virginia, 25801
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Birmingham, Alabama, 35294
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Cleveland, Ohio, 44195
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Decatur, Georgia, 30033
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Farmington, Connecticut, 06030
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Gainesville, Georgia, 30501
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Houston, Texas, 77054
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Indianapolis, Indiana, 46202
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Laguna Hills, California, 92653
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Madison, Wisconsin, 53705
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Marshfield, Wisconsin, 54449
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Montgomery, Alabama, 36111
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Morton Grove, Illinois, 60053
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Oakland, California, 94609
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Omaha, Nebraska, 68131
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Palm Harbor, Florida, 34684
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Peoria, Arizona, 85381
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Seattle, Washington, 98144
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Spokane, Washington, 99204
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Urbandale, Iowa, 50322

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Canada8 sites

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Hamilton, Ontario, L8N 1Y2
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London, Ontario, N6A 4V2
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Montreal, Quebec, H3A 1A1
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Sainte-Foy, Quebec, G1V 3M7
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Saskatoon, Saskatchewan, S7K 0H6
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Trois-Rivières, Quebec, G8Z 1Y2
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Vancouver, British Columbia, V6H 3X8
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Winnipeg, Manitoba, R3A 1M3

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Germany8 sites

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Braunfels, 35619
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Frankfurt, 60528
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Hamburg, 20354
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Heidelberg, D-69120
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Heinsberg, 52525
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Leipzig, 04207
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Marburg, 35033
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München, 80335

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Belgium7 sites

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Brussels, 1180
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Ghent, 9000
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Gozée, 6534
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Leuven, 3000
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Liège, 4000
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Tienen, 3300
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Yvoir, 5530

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Australia5 sites

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Keswick, South Australia, 5035
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Kogarah, New South Wales, 2217
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Malvern East, 3145
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Maroochydore, Queensland, 4558
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Randwick, Sydney, New South Wales, 2031

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France4 sites

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Amiens, 80084
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Orléans, 45000
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Paris, 75679
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Poitiers, 86000

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Spain4 sites

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Granada, 18012
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Madrid, 28046
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Salamanca, 37007
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Valencia, 46017

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Sweden4 sites

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Malmö, 21120
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Solna, 17176
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Umeå, 90185
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Uppsala, 75185

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Brazil3 sites

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Campinas, 13073-350
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Rio de Janeiro, 22271-100
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São Paulo, 01246-903

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Italy3 sites

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Siena, 53100
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Treviglio, 24047
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Valeggio sul Mincio, 37067

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Mexico3 sites

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León, 37000
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Mexico City, 14000
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Monterrey, 64461

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Puerto Rico2 sites

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Ponce, 00716
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San Juan, 00918

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Argentina1 site

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Buenos Aires, C1117ABH

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About this study

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

Conditions: Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture
Being tested: teriparatide, risedronate, placebo
Medical subject headings: Osteoporosis, Postmenopausal, Back Pain, Spinal Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

teriparatideDrug
Also called LY333334, Forteo, Forsteo
20 ug/day, subcutaneous, 18 months
risedronateDrug
Also called Actonel
35 mg/once weekly, oral, 18 months
placeboDrug
Also called LY333334, Forteo, Forsteo
once weekly, oral, 18 months
placeboDrug
Also called Actonel
daily, subcutaneous, 18 months

Study groups in NCT00343252
Study group	Role	What they receive
Teriparatide	Experimental	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo Receives: Drug: teriparatide; Drug: placebo
Risedronate	Active comparator	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo Receives: Drug: risedronate; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 Months

Secondary outcomes (20)

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.
Measured: 12 Months
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.
Measured: 6 Months
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.
Measured: 12 Months
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.
Measured: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
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.
Measured: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
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.
Measured: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
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.
Measured: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
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).
Measured: Baseline, 3 Months
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).
Measured: Baseline, 6 Months
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).
Measured: Baseline, 12 Months
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.
Measured: Baseline, 6 Months
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.
Measured: Baseline, 12 Months
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.
Measured: Baseline through 12 Months
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.
Measured: Baseline through 18 Months
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.
Measured: 18 Months
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.
Measured: 18 Months
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.
Measured: Baseline through 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
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.
Measured: Baseline through 18 Months
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.
Measured: Baseline, 18 Months
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.
Measured: Baseline, 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Jun 2010

First posted22 Jun 2006 (estimated)
Study startJun 2006
Primary completionJun 2009
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 712 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00343252
Sponsor's protocol ID: 9041
Other IDs: B3D-MC-GHCY
Status last verified: May 2011
First submitted: 20 Jun 2006
Last updated: 26 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures
ClinicalTrials.gov ID: NCT00343252
Acronym / sponsor ID: 9041
Conditions: Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 712 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Jun 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 22 Jun 2006 (estimated)
Results: Posted 12 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Teriparatide	Experimental	Drug: teriparatide, Drug: placeboTeriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Active comparator	Drug: risedronate, Drug: placeboRisedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
teriparatideAlso: LY333334, Forteo, Forsteo20 ug/day, subcutaneous, 18 months	Drug	Teriparatide
risedronateAlso: Actonel35 mg/once weekly, oral, 18 months	Drug	Risedronate
placeboAlso: LY333334, Forteo, Forsteoonce weekly, oral, 18 months	Drug	Teriparatide
placeboAlso: Actoneldaily, subcutaneous, 18 months	Drug	Risedronate

Primary outcome

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

20 secondary outcomes

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Time frame: 12 Months
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Time frame: 6 Months
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Time frame: 12 Months
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Time frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Time frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
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 frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
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 frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
Time frame: Baseline, 3 Months
Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Time frame: Baseline, 6 Months
Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
Time frame: Baseline, 12 Months
Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Time frame: Baseline, 6 Months
Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Time frame: Baseline, 12 Months
Number of Participants With Adverse Events (Safety) During 12 Months
Time frame: Baseline through 12 Months
Number of Participants With Adverse Events (Safety) During 18 Months
Time frame: Baseline through 18 Months
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Time frame: 18 Months
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Time frame: 18 Months
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
Time frame: Baseline through 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
Time frame: Baseline through 18 Months
Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
Time frame: Baseline, 18 Months
Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Time frame: Baseline, 18 Months

Results and safety

Results posted to the registry on 12 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teriparatide	361	259
Risedronate	351	269

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

Time frame: 6 Months. Number. Unit: participants

Measure	Teriparatide n = 348	Risedronate n = 336
Responder to Treatment	206	193
Non-Responder to Treatment	142	143

Teriparatide vs Risedronate: p = 0.642, Chi-square

Population analysed: Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 18 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teriparatide	55 of 360 (15.3%)	277 of 360 (76.9%)	Not reported
Risedronate	66 of 350 (18.9%)	273 of 350 (78%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Eli Lilly and Company

72 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing teriparatide and risedronate in people with Osteoporosis, Postmenopausal and Back Pain, run by Eli Lilly and Company at 72 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Canada, Germany, Belgium, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00343252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2011.