OsteoporosisPhase 2NCT00191867
Clinical Trial of Teriparatide in Japan
A Phase 2 study testing Teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 6 sites in Japan.
Trial summary
The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide
- How many people
- 160 participants
- Where
- 6 sitesJapan
- Study dates
- Feb 2005to Mar 2006
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese women with primary osteoporosis
- Postmenopausal women aged at least 55 years
- Patients with a high risk for fracture
Who cannot join
- History of metabolic bone disorders other than osteoporosis
- History of any secondary causes of osteoporosis
- History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated
- Severe or chronically disabling conditions other than osteoporosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hiroshima
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hyōgo
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Kagoshima
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Nagano
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Osaka
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Tokyo
About this study
Official title: Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis
The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- Teriparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint
Secondary outcomes (1)
To evaluate the safety of LY333334
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionMar 2006
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
- Double blind
- Enrolment
- 160 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
- NCT00191867
- Sponsor's protocol ID
- 8464
- Other IDs
- B3D-JE-GHCS
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 6 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dose Response of LY333334 in Japanese Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00191867
- Acronym / sponsor ID
- 8464
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 19 Sep 2005 (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 study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese women with primary osteoporosis
- Postmenopausal women aged at least 55 years
- Patients with a high risk for fracture
Key exclusion criteria (4 listed)
- History of metabolic bone disorders other than osteoporosis
- History of any secondary causes of osteoporosis
- History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated
- Severe or chronically disabling conditions other than osteoporosis
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 |
|---|---|---|
| Teriparatide | Drug | – |
Primary outcome
To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint
1 secondary outcome
To evaluate the safety of LY333334
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 6 Nov 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
6 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 Teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 6 sites in Japan.
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 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 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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 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?
To assess the dose response of LY333334 with the percent change from baseline in lumbar spine mineral density at endpoint. 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 6 Nov 2007.