Postmenopausal Bone LossPhase 3NCT00085956
Effects of Arzoxifene on Bone Mass and the Uterus
A Phase 3 study testing Arzoxifene in people with Postmenopausal Bone Loss, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purposes of this study are to determine: The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. The effects of arzoxifene on the uterus (womb) in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Bone Loss
- What is being tested?
- Arzoxifene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Feb 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 45 to 60 years of age, inclusive
- At least 2 years since last menstrual cycle
- Intact uterus (womb).
Who cannot join
- Existing fracture of the spine.
- Bone disorders, other than low bone mass
- History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
- Abnormal or unexplained vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, 92103
About this study
Official title: Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.
The purposes of this study are to determine:
- The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
- The effects of arzoxifene on the uterus (womb) in postmenopausal women.
- The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
- The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
- The safety of arzoxifene and any side effects that might be associated with its use.
- Conditions
- Postmenopausal Bone Loss
- Being tested
- Arzoxifene, Placebo
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArzoxifeneDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
Secondary outcomes (3)
The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
The effects of arzoxifene on breast density
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2004 (estimated)
- Study startApr 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Bone LossStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085956
- Sponsor's protocol ID
- 8537
- Other IDs
- H4Z-MC-GJAE
- Status last verified
- Mar 2007
- First submitted
- 18 Jun 2004
- Last updated
- 9 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT00085956
- Acronym / sponsor ID
- 8537
- Conditions
- Postmenopausal Bone Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Feb 2007
- First posted
- 22 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to determine:
- The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
- The effects of arzoxifene on the uterus (womb) in postmenopausal women.
- The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
- The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
- The safety of arzoxifene and any side effects that might be associated with its use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- 45 to 60 years of age, inclusive
- At least 2 years since last menstrual cycle
- Intact uterus (womb).
Key exclusion criteria (4 listed)
- Existing fracture of the spine.
- Bone disorders, other than low bone mass
- History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
- Abnormal or unexplained vaginal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arzoxifene | Drug | – |
| Placebo | Drug | – |
Primary outcome
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
3 secondary outcomes
The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
The effects of arzoxifene on breast density
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arzoxifene in people with Postmenopausal Bone Loss, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2007.