OsteoporosisPhase 4NCT00035971

EVA: Evista Alendronate Comparison

A Phase 4 study testing raloxifene HCI and alendronate Na in people with Osteoporosis, run by Eli Lilly and Company at 86 sites in 2 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 this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures Read more about this study

Who is it for?: Ages 50 to 80 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: raloxifene HCI and alendronate Na
How many people: Not given
Where: 86 sitesin 2 countries
Study dates: Start not givento not given
Phase: Phase 4
Are there results?: None posted in the registry

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 50 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

50-80 years of age, inclusive
2 years since last menses
Dx femoral neck osteoporosis
No vertebral fractures

Who cannot join

Poor candidate for study drugs
Hx of diseases affecting bone metabolism
Hx of breast/estrogen-dependent cancer
Current use of osteoporosis drug therapy
Hx/high risk of VTE

Trial locations and contacts

86 sites in 2 countries.

Country

City, postcode or hospital

86 sites in 2 countries

United States73 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
Albany, New York
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Albuquerque, New Mexico
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Anaheim, California
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Anniston, Alabama
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Austin, Texas
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Bangor, Maine
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Beachwood, Ohio
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Beverly Hills, California
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Boise, Idaho
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Boston, Massachusetts
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Burlington, Vermont
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Canton, Ohio
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Charlotte, North Carolina
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Charlottesville, Virginia
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Chicago, Illinois
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Cincinnati, Ohio
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Dallas, Texas
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Decatur, Georgia
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Des Moines, Iowa
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Detroit, Michigan
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Evansville, Indiana
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Fayetteville, Georgia
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Frederick, Maryland
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Gainesville, Georgia
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Greensboro, North Carolina
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Greenville, North Carolina
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Hagerstown, Maryland
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Honolulu, Hawaii
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Johnston, Rhode Island
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Lakewood, Colorado
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Lebanon, New Hampshire
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Lexington, Kentucky
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Loma Linda, California
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Madison, Wisconsin
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Maitland, Florida
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Miami, Florida
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Minneapolis, Minnesota
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Morehead City, North Carolina
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Morton Grove, Illinois
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New York, New York
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Newport News, Virginia
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Oakland, California
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Omaha, Nebraska
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Overland Park, Kansas
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Passaic, New Jersey
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Portland, Oregon
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Providence, Rhode Island
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Richmond, Virginia
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Riverdale, Georgia
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Rochester, New York
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Salt Lake City, Utah
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San Antonio, Texas
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San Francisco, California
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Scottsdale, Arizona
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Seattle, Washington
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Spokane, Washington
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Springfield, Missouri
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St Louis, Missouri
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Tacoma, Washington
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Tampa, Florida
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Temple, Texas
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The Bronx, New York
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Trumbull, Connecticut
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Tucson, Arizona
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Tulsa, Oklahoma
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Walnut Creek, California
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West Palm Beach, Florida

Other trials in United States

Canada13 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Burlington, Ontario
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Calgary, Alberta
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Greater Sudbury, Ontario
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Hamilton, Ontario
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Kitchener, Ontario
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Moncton, New Brunswick
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Montreal, Quebec
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Ottawa, Ontario
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Sainte-Foy, Quebec
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Saskatoon, Saskatchewan
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Trois-Rivières, Quebec
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Vancouver, British Columbia
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Winnipeg, Manitoba

Other trials in Canada

About this study

The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures

Conditions: Osteoporosis
Being tested: raloxifene HCI and alendronate Na
Medical subject headings: Osteoporosis

What participants receive

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

raloxifene HCI and alendronate NaDrug

Timeline

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

First posted8 May 2002 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies 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 4
Primary purpose: Treatment

IDs, dates and publications

ClinicalTrials.gov ID: NCT00035971
Sponsor's protocol ID: 5548
Other IDs: H3S-US-GGKO
Status last verified: Jul 2006
First submitted: 7 May 2002
Last updated: 19 Jul 2006
Results posted: No

Publications

Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.
PubMed 17182297

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

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
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Enrolling by invitationObservational study
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Osteoporosis

All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EVA: Evista Alendronate Comparison
ClinicalTrials.gov ID: NCT00035971
Acronym / sponsor ID: 5548
Conditions: Osteoporosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
First posted: 8 May 2002 (estimated)
Results: Not posted in the source record

Clinical summary

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

The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures

Study design

Primary purpose: Treatment

Who may qualify

Ages: 50 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

50-80 years of age, inclusive
2 years since last menses
Dx femoral neck osteoporosis
No vertebral fractures

Key exclusion criteria (5 listed)

Poor candidate for study drugs
Hx of diseases affecting bone metabolism
Hx of breast/estrogen-dependent cancer
Current use of osteoporosis drug therapy
Hx/high risk of VTE

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
raloxifene HCI and alendronate Na	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2006.
Derived from this study: PubMed 17182297Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.

Related trials for Osteoporosis

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis

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.

The record lists no contact. Use the official record to reach the sponsor.

86 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing raloxifene HCI and alendronate Na in people with Osteoporosis, run by Eli Lilly and Company at 86 sites in 2 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 4 inclusion and 5 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 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00035971, which also lists 1 linked publication.

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 19 Jul 2006.