Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00046137

Purpose

The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: teriparatide Drug: raloxifene Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Teriparatide Raloxifene hydrochloride Raloxifene Teriparatide acetate

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Must be diagnosed with osteoporosis.
Must be female, age 45 through 85.
Must be at least 5 years postmenopausal.
Must be free of other severe or chronically disabling conditions.
Must be able to properly use injection device.

Exclusion Criteria

Must not have bone diseases other than osteoporosis.
Must not have history of certain cancers.
Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes).
Must not have taken or are currently taking certain types of medicines.
Must not have known allergy to the study agent or SERM.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046137

Locations

United States, California
"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".
Anaheim, California, United States, 92801
"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".
Oakland, California, United States, 94612
United States, Florida
"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".
Altamonte Springs, Florida, United States, 32714
United States, Illinois
"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".
Chicago, Illinois, United States, 60622
United States, Iowa
"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".
Cedar Rapids, Iowa, United States, 52401
United States, Maryland
"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".
Baltimore, Maryland, United States, 21204
"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".
Hagerstown, Maryland, United States, 21740
United States, New Jersey
"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".
Voorhees, New Jersey, United States, 08043
United States, Ohio
"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".
Cleveland, Ohio, United States, 44195
United States, Oklahoma
"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".
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
"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".
Portland, Oregon, United States, 97213
United States, Pennsylvania
"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".
Duncansville, Pennsylvania, United States, 16635
United States, Texas
"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".
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00046137 History of Changes
Other Study ID Numbers:	6817, B3D-MC-GHCD
Study First Received:	September 20, 2002
Last Updated:	July 19, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Raloxifene
Bone Density Conservation Agents

Physiological Effects of Drugs
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Estrogen Antagonists

ClinicalTrials.gov processed this record on February 12, 2012