Osteoporosis, PostmenopausalPhase 3NCT00088010
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
A Phase 3 study testing Arzoxifene in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this trial is to study: Effects of arzoxifene on bone fractures and bone mass. Effects of arzoxifene on getting breast cancer. Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Arzoxifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,369 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Nov 2009
- 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 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60-85 years of age
- Female
- At least two years since last menstrual cycle
Who cannot join
- Abnormal or unexplained vaginal bleeding.
- Bone disorders, other than osteoporosis or low bone mass
- History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
- History of cerebral vascular accidents or venous thromboembolic events
- Medications outlined
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Elk Grove, Illinois, 60007
About this study
Official title: Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
The purpose of this trial is to study:
- Effects of arzoxifene on bone fractures and bone mass.
- Effects of arzoxifene on getting breast cancer.
- Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
- Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
- Effects of arzoxifene on the uterus.
- The safety of arzoxifene and any side effects.
- Conditions
- Osteoporosis, Postmenopausal
- 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
Also called LY353381
20mg, oral, tablet, once a day for 36 months
PlaceboDrug
oral, tablet, once a day for 36 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Arzoxifene |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of arzoxifene on bone fractures and bone mass
Measured: 5 years
Effects of arzoxifene on getting breast cancer
Measured: 5 years
The safety of arzoxifene and any side effects
Measured: 5 years
Secondary outcomes (5)
Effects of arzoxifene on certain types of cardiovascular events
Measured: 5 years
Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health
Measured: 5 years
Effects of arzoxifene on the uterus
Measured: 5 years
Effects of arzoxifene on cognition
Measured: 5 years
Effects of arzoxifene on back pain
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2004 (estimated)
- Study startJun 2004
- Primary completionJun 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,369 participants (actual)
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
- NCT00088010
- Sponsor's protocol ID
- 8536
- Other IDs
- H4Z-MC-GJAD
- Status last verified
- May 2010
- First submitted
- 19 Jul 2004
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
e Silva AV, Lacativa PG, Russo LA, de Gregorio LH, Pinheiro RA, Marinheiro LP. Association of back pain with hypovitaminosis D in postmenopausal women with low bone mass. BMC Musculoskelet Disord. 2013 Jun 12;14:184. doi: 10.1186/1471-2474-14-184.
PubMed 23758943Powles TJ, Diem SJ, Fabian CJ, Neven P, Wickerham DL, Cox DA, Muram D, Agnusdei D, Dowsett SA, Amewou-Atisso M, Cummings SR. Breast cancer incidence in postmenopausal women with osteoporosis or low bone mass using arzoxifene. Breast Cancer Res Treat. 2012 Jul;134(1):299-306. doi: 10.1007/s10549-012-2041-5. Epub 2012 Apr 8.
PubMed 22484799Goldstein SR, Bhattoa HP, Neven P, Cox DA, Dowsett SA, Alam J, Sipos A, Muram D. Gynecologic effects of arzoxifene in postmenopausal women with osteoporosis or low bone mass. Menopause. 2012 Jan;19(1):41-7. doi: 10.1097/gme.0b013e318223bbf4.
PubMed 21993078Cummings SR, McClung M, Reginster JY, Cox D, Mitlak B, Stock J, Amewou-Atisso M, Powles T, Miller P, Zanchetta J, Christiansen C. Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women. J Bone Miner Res. 2011 Feb;26(2):397-404. doi: 10.1002/jbmr.191. Epub 2010 Jul 23.
PubMed 20658564
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
- ClinicalTrials.gov ID
- NCT00088010
- Acronym / sponsor ID
- 8536
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,369 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Jul 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 purpose of this trial is to study:
- Effects of arzoxifene on bone fractures and bone mass.
- Effects of arzoxifene on getting breast cancer.
- Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
- Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
- Effects of arzoxifene on the uterus.
- The safety of arzoxifene and any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Arzoxifene |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60-85 years of age
- Female
- At least two years since last menstrual cycle
Key exclusion criteria (5 listed)
- Abnormal or unexplained vaginal bleeding.
- Bone disorders, other than osteoporosis or low bone mass
- History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
- History of cerebral vascular accidents or venous thromboembolic events
- Medications outlined
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 |
|---|---|---|
| ArzoxifeneAlso: LY35338120mg, oral, tablet, once a day for 36 months | Drug | 1 |
| Placebooral, tablet, once a day for 36 months | Drug | 2 |
Primary outcome
Effects of arzoxifene on bone fractures and bone mass
Time frame: 5 years
Effects of arzoxifene on getting breast cancer
Time frame: 5 years
The safety of arzoxifene and any side effects
Time frame: 5 years
5 secondary outcomes
Effects of arzoxifene on certain types of cardiovascular events
Time frame: 5 years
Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health
Time frame: 5 years
Effects of arzoxifene on the uterus
Time frame: 5 years
Effects of arzoxifene on cognition
Time frame: 5 years
Effects of arzoxifene on back pain
Time frame: 5 years
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 2 Jun 2010.
- Derived from this study: PubMed 23758943e Silva AV, Lacativa PG, Russo LA, de Gregorio LH, Pinheiro RA, Marinheiro LP. Association of back pain with hypovitaminosis D in postmenopausal women with low bone mass. BMC Musculoskelet Disord. 2013 Jun 12;14:184. doi: 10.1186/1471-2474-14-184.
- Derived from this study: PubMed 22484799Powles TJ, Diem SJ, Fabian CJ, Neven P, Wickerham DL, Cox DA, Muram D, Agnusdei D, Dowsett SA, Amewou-Atisso M, Cummings SR. Breast cancer incidence in postmenopausal women with osteoporosis or low bone mass using arzoxifene. Breast Cancer Res Treat. 2012 Jul;134(1):299-306. doi: 10.1007/s10549-012-2041-5. Epub 2012 Apr 8.
- Derived from this study: PubMed 21993078Goldstein SR, Bhattoa HP, Neven P, Cox DA, Dowsett SA, Alam J, Sipos A, Muram D. Gynecologic effects of arzoxifene in postmenopausal women with osteoporosis or low bone mass. Menopause. 2012 Jan;19(1):41-7. doi: 10.1097/gme.0b013e318223bbf4.
- Derived from this study: PubMed 20658564Cummings SR, McClung M, Reginster JY, Cox D, Mitlak B, Stock J, Amewou-Atisso M, Powles T, Miller P, Zanchetta J, Christiansen C. Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women. J Bone Miner Res. 2011 Feb;26(2):397-404. doi: 10.1002/jbmr.191. Epub 2010 Jul 23.
- 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 Osteoporosis, Postmenopausal, 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 3 inclusion and 5 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 2 Jun 2010. 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. Some participants in this study may receive a placebo. 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?
Effects of arzoxifene on bone fractures and bone mass (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT00088010, which also lists 4 linked publications.
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 2 Jun 2010.