OsteoporosisPhase 3CORALNCT00163137
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
A Phase 3 study testing lasofoxifene and raloxifene in people with Osteoporosis, run by Ligand Pharmaceuticals at 72 sites in United States.
Trial summary
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine. Read more about this study
- Who is it for?
- Ages 48 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- lasofoxifene and raloxifene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 72 sitesUnited States
- Study dates
- May 2003to Oct 2005
- 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 48 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings
Who cannot join
- Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
- Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United States72 sites
Pfizer Investigational Site
Akron, Ohio, 44312-1647
Pfizer Investigational Site
Akron, Ohio, 44314
Pfizer Investigational Site
Albany, California, 94706
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
American Fork, Utah, 84003
Pfizer Investigational Site
Arden Hills, Minnesota, 55112
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Berkeley, California, 94705
Pfizer Investigational Site
Bethesda, Maryland, 20817
Pfizer Investigational Site
Brandon, Florida, 33511-5964
Pfizer Investigational Site
Chattanooga, Tennessee, 37403
Pfizer Investigational Site
Chattanooga, Tennessee, 37412
Pfizer Investigational Site
Chesapeake, Virginia, 23320
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Cordova, Tennessee, 38018
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Des Moines, Iowa, 50309
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48236
Pfizer Investigational Site
Gainesville, Florida, 32605
Pfizer Investigational Site
Gainesville, Florida, 32607
Pfizer Investigational Site
Gaithersberg, Maryland, 20886
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Key Largo, Florida, 33037
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92093-0659
Pfizer Investigational Site
Lake Worth, Florida, 33461
Pfizer Investigational Site
Leesburg, Florida, 34748
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Minneapolis, Minnesota, 55415-1226
Pfizer Investigational Site
Monessen, Pennsylvania, 15062
Pfizer Investigational Site
Mosessen, Pennsylvania, 15062
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Newark, Delaware, 19713-2094
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Oakland, California, 94609
Pfizer Investigational Site
Oakland, California, 94612
Pfizer Investigational Site
Palo Alto, California, 94304
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pleasant Grove, Utah, 84062
Pfizer Investigational Site
Portland, Maine, 04102
Pfizer Investigational Site
Portland, Oregon, 97213
Pfizer Investigational Site
Portland, Oregon, 97220
Pfizer Investigational Site
Poway, California, 92064
Pfizer Investigational Site
Provo, Utah, 84064
Pfizer Investigational Site
Richmond, Virginia, 23221
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Richmond, Virginia, 23229
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Richmond, Virginia, 23454
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98144
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Tampa, Florida, 33613-3946
Pfizer Investigational Site
Tampa, Florida, 33614-7118
Pfizer Investigational Site
Virginia Beach, Virginia, 23454
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
West Reading, Pennsylvania, 19611
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610-2132
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610
About this study
Official title: Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Mg/D and Raloxifene 60Mg/D For The Prevention Of Bone Loss In Postmenopausal Women
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
- Conditions
- Osteoporosis
- Being tested
- lasofoxifene, raloxifene, 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
lasofoxifene 0.25mg
raloxifeneDrug
raloxifene 60 mg/day
PlaceboDrug
0 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Lasofoxifene 0.25 mg | Experimental | lasofoxifene 0.25 mg/day Receives: Drug: lasofoxifene |
| raloxifene | Active comparator | raloxifene 60 mg/day Receives: Drug: raloxifene |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spine BMD after 2 years
Lumbar Spine Bome Mineral Density
Measured: 2 years
Secondary outcomes (1)
Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Direct low density lipoprotein cholesterol (LDL-C) at 24 months, vaginal pH at 24 months, vaginal epithelial parabasal cells at 12 months, and total hip BMD at 24 months.
Measured: Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionOct 2005
- Study completionOct 2005
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 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
- NCT00163137
- Sponsor's protocol ID
- A2181030
- Acronym
- CORAL
- Status last verified
- Aug 2011
- First submitted
- 9 Sep 2005
- Last updated
- 12 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Mg/D and Raloxifene 60Mg/D For The Prevention Of Bone Loss In Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00163137
- Acronym / sponsor ID
- CORAL / A2181030
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 13 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 compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lasofoxifene 0.25 mg | Experimental | Drug: lasofoxifenelasofoxifene 0.25 mg/day |
| raloxifene | Active comparator | Drug: raloxifeneraloxifene 60 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 48 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings
Key exclusion criteria (2 listed)
- Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
- Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.
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 |
|---|---|---|
| lasofoxifenelasofoxifene 0.25mg | Drug | Lasofoxifene 0.25 mg |
| raloxifeneraloxifene 60 mg/day | Drug | raloxifene |
| Placebo0 mg/day | Drug | Placebo |
Primary outcome
Spine BMD after 2 years
Time frame: 2 years
Lumbar Spine Bome Mineral Density
1 secondary outcome
Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Time frame: Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 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 12 Aug 2011.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lasofoxifene and raloxifene in people with Osteoporosis, run by Ligand Pharmaceuticals at 72 sites 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 1 inclusion and 2 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 12 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 72 sites 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?
Spine BMD after 2 years (time frame: 2 years). 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 12 Aug 2011.