OsteoporosisPhase 2NCT00767299
A Study of Arzoxifene to Treat Korean Women With Osteoporosis
A Phase 2 study testing arzoxifene in people with Osteoporosis, run by Eli Lilly and Company at 2 sites in South Korea.
Trial summary
The study is for Korean women who are postmenopausal and also suffer from osteoporosis. The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- arzoxifene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 2
- 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
- Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score of less than or equal to -2.5 but must never have had any osteoporotic fragility fracture.
- Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed osteoporosis (Inclusion Criterion [1]), all women must be free of severe or chronically disabling conditions, have a life expectancy of at least 5 years in the opinion of the investigator, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits.
- Had their last natural menstrual period at least 2 years before beginning the study.
- Are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study.
- Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be adequately evaluated for existing vertebral fractures at screening.
- Have centrally read total hip, femoral neck or lumbar spine T-score less than or equal to -2.5
Who cannot join
- Have known current metabolic bone disorders other than low bone mass, such as hyperparathyroidism, renal osteodystrophy, or osteomalacia.
- Have known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized patients with a history of carcinoma in situ of the uterus. For other cancers, be disease free and in remission from all other cancers for 5 or more years, except for excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma of the skin.
- Have demonstrated or suspected allergy to raloxifene or arzoxifene
- Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or between Visit 1 and Visit 2.
- Are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy.
- Have a history of or suggestion on ultrasound or pelvic examination of a pre-existing gynecologic abnormality that would require further gynecologic treatment (e.g., ovarian cysts, large fibroids, undiagnosed adnexal masses) or of baseline endometrial thickness of >5 mm.
Show all 18Show fewer
- Have Papanicolaou's tests showing malignant or premalignant findings.
- Have active or any past history of thromboembolic events
- Have active or any past history of atrial fibrillation.
- Have a history of cerebrovascular accident or documented transient ischemic attack at any time in the past.
- Have acute or chronic liver disease defined as alanine aminotransaminase (ALT) >100 U/L, gamma-glutamyl transferase (GGT) >400 U/L, or late stage cirrhosis without transaminase elevations.
- Have impaired kidney function (serum creatinine >177 micromol/L or >2.0 mg/dL).
- Have vitamin D deficiency prior to enrollment (Visit 2; 25-hydroxyvitamin D less than10 ng/mL or less than 24.9 nmol/L).
- Have any known, severe, or untreated malabsorption syndromes.
- Have endocrine disorders requiring pharmacologic therapy except for type II diabetes and hypothyroidism. Patients on a stable dose of thyroid replacement therapy during the 6 months preceding randomization (Visit 2) who are clinically euthyroid in the opinion of the investigator may enroll in the trial.
- Consume an excess of alcohol or abuse drugs
- Represent an unacceptable medical or psychiatric risk for treatment with an investigational drug
- Have active or any history of seizure disorder.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bucheon-si, 420-767
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, 138-736
About this study
Official title: Effects of Arzoxifene on Bone Mineral Density in Korean Postmenopausal Women With Osteoporosis
The study is for Korean women who are postmenopausal and also suffer from osteoporosis.
The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene.
All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.
- Conditions
- Osteoporosis
- Being tested
- arzoxifene, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arzoxifeneDrug
Also called LY353381
20 mg, QD, PO,24 weeks
PlaceboDrug
QD, PO, 24 weeks
| 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.
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
Measured: 6 months
Secondary outcomes (4)
Incidence of spontaneous vaginal bleeding.
Measured: 6 months
Total hip BMD
Measured: 6 months
Biochemical marker of bone metabolism (serum CTX and PINP)
Measured: 3 and to 6 months
Overall safety of arzoxifene administration in Korean postmenopausal women
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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
- NCT00767299
- Sponsor's protocol ID
- 12185
- Other IDs
- H4Z-MC-GJAV
- Status last verified
- Apr 2015
- First submitted
- 3 Oct 2008
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arzoxifene on Bone Mineral Density in Korean Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00767299
- Acronym / sponsor ID
- 12185
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Oct 2008 (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 study is for Korean women who are postmenopausal and also suffer from osteoporosis.
The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene.
All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.
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 (6 listed)
- Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score of less than or equal to -2.5 but must never have had any osteoporotic fragility fracture.
- Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed osteoporosis (Inclusion Criterion [1]), all women must be free of severe or chronically disabling conditions, have a life expectancy of at least 5 years in the opinion of the investigator, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits.
- Had their last natural menstrual period at least 2 years before beginning the study.
- Are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study.
- Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be adequately evaluated for existing vertebral fractures at screening.
Key exclusion criteria (18 listed)
- Have known current metabolic bone disorders other than low bone mass, such as hyperparathyroidism, renal osteodystrophy, or osteomalacia.
- Have known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized patients with a history of carcinoma in situ of the uterus. For other cancers, be disease free and in remission from all other cancers for 5 or more years, except for excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma of the skin.
- Have demonstrated or suspected allergy to raloxifene or arzoxifene
- Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or between Visit 1 and Visit 2.
- Are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy.
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: LY35338120 mg, QD, PO,24 weeks | Drug | 1 |
| PlaceboQD, PO, 24 weeks | Drug | 2 |
Primary outcome
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
Time frame: 6 months
4 secondary outcomes
Incidence of spontaneous vaginal bleeding.
Time frame: 6 months
Total hip BMD
Time frame: 6 months
Biochemical marker of bone metabolism (serum CTX and PINP)
Time frame: 3 and to 6 months
Overall safety of arzoxifene administration in Korean postmenopausal women
Time frame: 6 months
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 30 Apr 2015.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arzoxifene in people with Osteoporosis, run by Eli Lilly and Company at 2 sites in South Korea.
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 6 inclusion and 18 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses (time frame: 6 months). 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 30 Apr 2015.