NCT00046137

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

13 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

First Submitted

Initial submission to the registry

September 20, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2002

Completed
Last Updated

July 20, 2006

Status Verified

July 1, 2006

First QC Date

September 20, 2002

Last Update Submit

July 19, 2006

Conditions

Interventions

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

"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, 92801, United States

Location

"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, 94612, United States

Location

"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, 32714, United States

Location

"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, 60622, United States

Location

"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, 52401, United States

Location

"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, 21204, United States

Location

"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, 21740, United States

Location

"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 Township, New Jersey, 08043, United States

Location

"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, 44195, United States

Location

"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, 73109, United States

Location

"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, 97213, United States

Location

"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, 16635, United States

Location

"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, 75231, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

TeriparatideRaloxifene Hydrochloride

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsTamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 20, 2002

First Posted

September 23, 2002

Last Updated

July 20, 2006

Record last verified: 2006-07

Locations