Clinical trial NCT00046137: Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-09-23
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: "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".
state: California
city: Oakland
country: United States
facility: "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".
state: California
city: Altamonte Springs
country: United States
facility: "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".
state: Florida
city: Chicago
country: United States
facility: "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".
state: Illinois
city: Cedar Rapids
country: United States
facility: "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".
state: Iowa
city: Baltimore
country: United States
facility: "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".
state: Maryland
city: Hagerstown
country: United States
facility: "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".
state: Maryland
city: Voorhees
country: United States
facility: "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".
state: New Jersey
city: Cleveland
country: United States
facility: "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".
state: Ohio
city: Oklahoma City
country: United States
facility: "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".
state: Oklahoma
city: Portland
country: United States
facility: "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".
state: Oregon
city: Duncansville
country: United States
facility: "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".
state: Pennsylvania
city: Dallas
country: United States
facility: "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".
state: Texas
Study officials:
References: