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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

712

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach

13 countries

72 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

June 1, 2006

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

1 month until next milestone

Results Posted

Study results publicly available

July 12, 2010

Completed

Last Updated

May 26, 2011

Status Verified

May 1, 2011

Enrollment Period

3 years

First QC Date

June 20, 2006

Results QC Date

June 8, 2010

Last Update Submit

May 20, 2011

Conditions

Osteoporosis, Postmenopausal Back Pain Spinal Fracture

Outcome Measures

Primary Outcomes (1)

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.
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
12 Months
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
6 Months
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
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
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
Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
+15 more secondary outcomes

Study Arms (2)

Teriparatide

EXPERIMENTAL

Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo

Drug: teriparatideDrug: placebo

Risedronate

ACTIVE COMPARATOR

Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Drug: risedronateDrug: placebo

Interventions

teriparatideDRUG

20 ug/day, subcutaneous, 18 months

Also known as: LY333334, Forteo, Forsteo

Teriparatide

risedronateDRUG

35 mg/once weekly, oral, 18 months

Also known as: Actonel

Risedronate

placeboDRUG

once weekly, oral, 18 months

Also known as: LY333334, Forteo, Forsteo

Teriparatide

Eligibility Criteria

Age45 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (72)

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.

Birmingham, Alabama, 35294, United States

Location

Montgomery, Alabama, 36111, United States

Location

Peoria, Arizona, 85381, United States

Location

Laguna Hills, California, 92653, United States

Location

Oakland, California, 94609, United States

Location

Farmington, Connecticut, 06030, United States

Location

Palm Harbor, Florida, 34684, United States

Location

Decatur, Georgia, 30033, United States

Location

Gainesville, Georgia, 30501, United States

Location

Morton Grove, Illinois, 60053, United States

Location

Indianapolis, Indiana, 46202, United States

Location

Urbandale, Iowa, 50322, United States

Location

Omaha, Nebraska, 68131, United States

Location

Cleveland, Ohio, 44195, United States

Location

Houston, Texas, 77054, United States

Location

Seattle, Washington, 98144, United States

Location

Spokane, Washington, 99204, United States

Location

Beckley, West Virginia, 25801, United States

Location

Madison, Wisconsin, 53705, United States

Location

Marshfield, Wisconsin, 54449, United States

Location

Buenos Aires, C1117ABH, Argentina

Location

Kogarah, New South Wales, 2217, Australia

Location

Randwick, Sydney, New South Wales, 2031, Australia

Location

Maroochydore, Queensland, 4558, Australia

Location

Keswick, South Australia, 5035, Australia

Location

Malvern East, 3145, Australia

Location

Brussels, 1180, Belgium

Location

Ghent, 9000, Belgium

Location

Gozée, 6534, Belgium

Location

Leuven, 3000, Belgium

Location

Liège, 4000, Belgium

Location

Tienen, 3300, Belgium

Location

Yvoir, 5530, Belgium

Location

Campinas, 13073-350, Brazil

Location

Rio de Janeiro, 22271-100, Brazil

Location

São Paulo, 01246-903, Brazil

Location

Vancouver, British Columbia, V6H 3X8, Canada

Location

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Hamilton, Ontario, L8N 1Y2, Canada

Location

London, Ontario, N6A 4V2, Canada

Location

Montreal, Quebec, H3A 1A1, Canada

Location

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Amiens, 80084, France

Location

Orléans, 45000, France

Location

Paris, 75679, France

Location

Poitiers, 86000, France

Location

Braunfels, 35619, Germany

Location

Frankfurt, 60528, Germany

Location

Hamburg, 20354, Germany

Location

Heidelberg, D-69120, Germany

Location

Heinsberg, 52525, Germany

Location

Leipzig, 04207, Germany

Location

Marburg, 35033, Germany

Location

München, 80335, Germany

Location

Siena, 53100, Italy

Location

Treviglio, 24047, Italy

Location

Valeggio sul Mincio, 37067, Italy

Location

León, 37000, Mexico

Location

Mexico City, 14000, Mexico

Location

Monterrey, 64461, Mexico

Location

Ponce, 00716, Puerto Rico

Location

San Juan, 00918, Puerto Rico

Location

Granada, 18012, Spain

Location

Madrid, 28046, Spain

Location

Salamanca, 37007, Spain

Location

Valencia, 46017, Spain

Location

Malmo, 21120, Sweden

Location

Solna, 17176, Sweden

Location

Umeå, 90185, Sweden

Location

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Osteoporosis, PostmenopausalBack PainSpinal Fractures

Interventions

TeriparatideRisedronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 22, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

May 26, 2011

Results First Posted

July 12, 2010

Record last verified: 2011-05

Locations

SE(4)AU(5)BE(7)BR(3)IT(3)AR(1)DE(8)US(20)CA(8)ME(3)FR(4)PR(2)ES(4)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (2)

Teriparatide

Risedronate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (72)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (2)

Teriparatide

Risedronate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (72)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations