EVA: Evista Alendronate Comparison

This study has been completed.

First Received: May 7, 2002 Last Updated: July 18, 2006 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00035971

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: raloxifene HCI and alendronate Na	Phase IV

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Raloxifene hydrochloride Raloxifene Alendronate sodium Fosamax

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035971

Show 86 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2006 Dec 19.

Study ID Numbers:	5548, H3S-US-GGKO
Study First Received:	May 7, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00035971 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Raloxifene
Musculoskeletal Diseases
Alendronate
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009