OsteoporosisPhase 2JADENCT00143273
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation
A Phase 2 study testing lasofoxifene in people with Osteoporosis, run by Ligand Pharmaceuticals at 17 sites in 4 countries.
Trial summary
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- lasofoxifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 497 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Jun 2004to 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal Asian women with osteoporosis defined by low BMD
Who cannot join
- Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Japan10 sites
Pfizer Investigational Site
Fuchū, Tokyo, 183-0051
Pfizer Investigational Site
Fukuoka, Fukuoka, 810-0021
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, 892-0824
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, 892-0845
Pfizer Investigational Site
Kiyose, Tokyo, 204-0021
Pfizer Investigational Site
Minato-ku, Tokyo, 106-0032
Pfizer Investigational Site
Minato-ku, Tokyo, 108-0075
Pfizer Investigational Site
Miyazaki, Miyazaki, 880-0052
Pfizer Investigational Site
Setagaya-ku, Tokyo, 157-0066
Pfizer Investigational Site
Yonago-shi, Tottori, 683-8504
South Korea3 sites
Pfizer Investigational Site
Kangnam-ku, Seoul, 135-710
Pfizer Investigational Site
Sonpagu, Seoul, 138-736
Pfizer Investigational Site
Youngdeungpo-gu, Seoul, 150-713
Taiwan3 sites
Pfizer Investigational Site
Changhua
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taoyun 333
Location not given1 site
Pfizer Investigational Site
About this study
Official title: Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
- Conditions
- Osteoporosis
- Being tested
- lasofoxifene, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lasofoxifeneDrug
0.05 mg tablets
PlaceboDrug
0 mg
LasofoxifeneDrug
0.25 mg tablets
LasofoxifeneDrug
0.5 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Lasofoxifene Dose 1 | Experimental | 0.05 mg Receives: Drug: lasofoxifene |
| Lasofoxifene Dose 2 | Experimental | 0.25 mg Receives: Drug: Lasofoxifene |
| Lasofoxifene Dose 3 | Experimental | 0.5 mg Receives: Drug: Lasofoxifene |
| Placebo | Placebo comparator | 0 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
Percent change from baseline in lumbar spine BMD at Month 12
Measured: 12 months
Secondary outcomes (1)
Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year
Percent change from baseline in lumbar spine BMD at Month 6, percent change in baseline in hip BMD at Month 6 and Month 12, percent change from baseline in bone metabolism markers at Month 6 and Month 12, percent change from baseline in serum lipids, total cholesterol, high-density lipoprotein cholesterol, triglycerides, lipoprotein (a), apoliporpotein-A1, apolipoprotein-B at Month 6 and Month 12 and incidence of new vertebral fractures at Month 12
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2006
- 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.
- 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
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143273
- Sponsor's protocol ID
- A2181037
- Acronym
- JADE
- Status last verified
- Aug 2011
- First submitted
- 31 Aug 2005
- Last updated
- 10 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
- ClinicalTrials.gov ID
- NCT00143273
- Acronym / sponsor ID
- JADE / A2181037
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 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.
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lasofoxifene Dose 1 | Experimental | Drug: lasofoxifene0.05 mg |
| Lasofoxifene Dose 2 | Experimental | Drug: Lasofoxifene0.25 mg |
| Lasofoxifene Dose 3 | Experimental | Drug: Lasofoxifene0.5 mg |
| Placebo | Placebo comparator | Drug: Placebo0 mg |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- postmenopausal Asian women with osteoporosis defined by low BMD
Key exclusion criteria (1 listed)
- Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
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 |
|---|---|---|
| lasofoxifene0.05 mg tablets | Drug | Lasofoxifene Dose 1 |
| Placebo0 mg | Drug | Placebo |
| Lasofoxifene0.25 mg tablets | Drug | Lasofoxifene Dose 2 |
| Lasofoxifene0.5 mg tablets | Drug | Lasofoxifene Dose 3 |
Primary outcome
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
Time frame: 12 months
Percent change from baseline in lumbar spine BMD at Month 12
1 secondary outcome
Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year
Time frame: Month 6 and Month 12
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 10 Aug 2011.
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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.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lasofoxifene in people with Osteoporosis, run by Ligand Pharmaceuticals at 17 sites in 4 countries.
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 1 inclusion and 1 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 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan, South Korea, Taiwan. 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?
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment (time frame: 12 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 10 Aug 2011.