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

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

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Raloxifene Raloxifene hydrochloride Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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".
	Hagerstown, Maryland, United States, 21740
	"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

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

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

Study placed in the following topic categories:

Raloxifene

Musculoskeletal Diseases

Teriparatide

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

Additional relevant MeSH terms:

Estrogen Receptor Modulators

Estrogen Antagonists

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Bone Density Conservation Agents

Selective Estrogen Receptor Modulators

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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