Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
NCT ID: NCT00343252
Last Updated: 2011-05-26
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
712 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-06-30
Study Completion Date
2010-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Osteoporosis, Postmenopausal
Back Pain
Spinal Fracture
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Teriparatide
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Group Type
EXPERIMENTAL
teriparatide
Intervention Type
DRUG
20 ug/day, subcutaneous, 18 months
placebo
Intervention Type
DRUG
once weekly, oral, 18 months
Risedronate
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Group Type
ACTIVE_COMPARATOR
risedronate
Intervention Type
DRUG
35 mg/once weekly, oral, 18 months
placebo
Intervention Type
DRUG
daily, subcutaneous, 18 months
Interventions
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teriparatide
20 ug/day, subcutaneous, 18 months
Intervention Type
DRUG
risedronate
35 mg/once weekly, oral, 18 months
Intervention Type
DRUG
placebo
once weekly, oral, 18 months
Intervention Type
DRUG
placebo
daily, subcutaneous, 18 months
Intervention Type
DRUG
Other Intervention Names
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LY333334
Forteo
Forsteo
Actonel
LY333334
Forteo
Forsteo
Actonel
Eligibility Criteria
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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.
* History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
* Minimum of one moderate spinal bone fracture.
* Beginning pain level of at least four on an eleven point scale.
* Bone Mineral Density (BMD) must meet criteria
* Able to read, understand, and administer self-questionnaires.
* Be willing and able to use a pen-injector to deliver the medication.
Exclusion Criteria
* Are at increased risk for osteosarcoma.
* Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
* Participants that already know that they will require procedures to repair their spinal bone fractures.
* Abnormal values of certain lab tests.
* Anything that would make it difficult to determine if the back pain was due to the fracture.
* Poor medical or psychiatric condition.
* Alcohol or drug abuse within a year of the study start.
* Certain malignant neoplasms in the 5 years prior to enrollment.
* Active liver disease or clinical jaundice.
* Significantly impaired renal function.
* History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
* Known contraindication or intolerance to risedronate and/or teriparatide therapy.
* Treatment with oral strontium or certain therapeutic doses of fluoride.
* 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.
Minimum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Eli Lilly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Granada, , Spain
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Valencia, , Spain
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Malmo, , Sweden
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Solna, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
Site Status
Countries
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United States
Argentina
Australia
Belgium
Brazil
Canada
France
Germany
Italy
Mexico
Puerto Rico
Spain
Sweden
Other Identifiers
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B3D-MC-GHCY
Identifier Type: OTHER
Identifier Source: secondary_id
9041
Identifier Type: -
Identifier Source: org_study_id
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Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis
NCT01535027
COMPLETED
PHASE4
Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
NCT01753856
COMPLETED
PHASE4
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
NCT00439244
COMPLETED
PHASE3
A Study of the Treatment of Postmenopausal Women With Osteoporosis
NCT00543023
COMPLETED
PHASE3
2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis
NCT00191425
COMPLETED
PHASE4
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
NCT00927186
COMPLETED
PHASE4
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
NCT01153425
COMPLETED
PHASE4
Phase 3 Clinical Trial of Teriparatide in Japan
NCT00433160
COMPLETED
PHASE3
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
NCT00670319
COMPLETED
PHASE3
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
NCT00383422
COMPLETED
PHASE3
Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD
NCT00624481
WITHDRAWN
PHASE2
A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women
NCT01250145
COMPLETED
PHASE1
Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
NCT00239629
COMPLETED
PHASE4
Clinical Trial of Teriparatide in Japan
NCT00191867
COMPLETED
PHASE2
Early Effects of Parathyroid Hormone (PTH) on the Proximal Femur
NCT01309399
COMPLETED
NA
Teriparatide Use in Hip Replaced Subjects
NCT00191321
COMPLETED
PHASE3
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
NCT00051558
COMPLETED
PHASE3