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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00343252

Purpose

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in postmenopausal women with osteoporosis that have back pain due to a spinal bone fracture.

Condition	Intervention	Phase
Osteoporosis, Postmenopausal Back Pain Spinal Fracture	Drug: teriparatide Drug: risedronate Drug: placebo	Phase III

MedlinePlus related topics: Back Pain Fractures Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Risedronic acid Risedronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Comparison of teriparatide versus risedronate on the reduction of back pain related to spinal bone fractures in osteoporotic postmenopausal women. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

11 point pain scale, severity of worst back pain, 30% reduction [ Time Frame: Baseline to 12 and 18 months ] [ Designated as safety issue: No ]
11 point pain scale, severity of average back pain, 30% reduction [ Time Frame: Baseline to 6, 12, and 18 months ] [ Designated as safety issue: No ]
Time to first occurrence, 30% reduction for worst back pain using mean score from 11 point pain scale [ Time Frame: Baseline to 6, 12, and 18 months ] [ Designated as safety issue: No ]
Roland Disability Questionnaire. [ Time Frame: Baseline to 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
QUALEFFO quality of life questionnaire [ Time Frame: Baseline to 6, 12, and 18 months ] [ Designated as safety issue: No ]
Time to first occurrence, 30% reduction for average back pain using mean score from 11 point pain scale [ Time Frame: Baseline to 6, 12, and 18 months ] [ Designated as safety issue: No ]
Safety [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	708
Study Start Date:	June 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Teriparatide 20 micrograms/day, subcutaneous, 18 months plus once weekly oral placebo	Drug: teriparatide 20 micrograms/day, subcutaneous, 18 months Drug: placebo 35mg/once weekly, oral, 18 months
B: Active Comparator Risedronate 35mg/once weekly, oral, 18 months plus daily injection placebo	Drug: risedronate 35mg/once weekly, oral, 18 months Drug: placebo 20 micrograms/day, subcutaneous, 18 months

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women 45 years or older. No period for at least two years.
History of back pain (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.
Patients 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343252

Show 72 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9041, B3D-MC-GHCY
Study First Received:	June 20, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00343252 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Teriparatide
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Calcium Channel Blockers
Osteoporosis
Disorders of Environmental Origin
Bone Density Conservation Agents
Pain
Bone Diseases, Metabolic
Cardiovascular Agents

Back Pain
Bone Diseases
Calcium, Dietary
Signs and Symptoms
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Osteoporosis, Postmenopausal
Neurologic Manifestations
Risedronic acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Teriparatide
Fractures, Bone
Physiological Effects of Drugs
Spinal Fractures
Disorders of Environmental Origin
Calcium Channel Blockers
Pain
Bone Density Conservation Agents
Bone Diseases
Membrane Transport Modulators
Signs and Symptoms
Musculoskeletal Diseases

Therapeutic Uses
Back Injuries
Risedronic acid
Nervous System Diseases
Wounds and Injuries
Osteoporosis
Bone Diseases, Metabolic
Cardiovascular Agents
Back Pain
Pharmacologic Actions
Spinal Injuries
Osteoporosis, Postmenopausal
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009