Metastatic Prostate CancerPhase 3NCT00216060
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
A Phase 3 study testing Risedronate in people with Metastatic Prostate Cancer, run by Christopher Sweeney, MBBS at 45 sites in 2 countries.
Trial summary
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Oct 2003to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, MRI or bone scan) with plans to start or be < 30 days from beginning androgen deprivation therapy. Patients with lymph node or visceral metastases only are not eligible
- Patients may receive palliative radiation therapy at the investigators discretion during the first 4 weeks of beginning protocol therapy.
Who cannot join
- No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing's disease).
- No use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates.
- No major surgery within 4 weeks of registration to protocol therapy.
- No adjuvant chemotherapy within 6 months of registration to protocol therapy.
- No previous chemotherapy for metastatic disease.
- No hormonal therapy in the adjuvant setting within 12 months of registration to protocol therapy; previous hormonal therapy must not have exceeded 6 months.
- No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin.
- No history of allergy or drug reactions to bisphosphonates.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States31 sites
Urologic Surgery Associates
Baltimore, Maryland, 21201
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Accumed Research Associates
Garden City, New York, 11530
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527
Drs. Werner, Murdock and Francis PA Urology Associates
Greenbelt, Maryland, 20770
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Urology of Indiana, LLC
Indianapolis, Indiana, 46202
Kansas City Urology Care
Kansas City, Missouri, 64131
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Center for Urological Research
La Mesa, California, 91942
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604
Urology Associates
Muncie, Indiana, 47303
Grove Hill Medical Center Urology
New Britain, Connecticut, 06052
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Peoria Urological Associates
Peoria, Illinois, 61614
Triangle Urological Group
Pittsburgh, Pennsylvania, 15212
Nevada Urology
Reno, Nevada, 89511
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Salt Lake Research
Salt Lake City, Utah, 84124
San Bernadino Urological Associates
San Bernardino, California, 92404
David Reed, M.D.
Seattle, Washington, 98166
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Oregon Urology Specialists
Springfield, Oregon, 97477
Siteman Cancer Center
St Louis, Missouri, 63110
Staten Island Urological Research, P.C.
Staten Island, New York, 10304
Madigan Army Medical Center Urology Service
Tacoma, Washington, 98431
Innovative Surgical Resources
Tampa, Florida, 33607
Lawrenceville Urology
Trenton, New Jersey, 08648
Canada14 sites
Male/Female Health and Research
Barrie, Ontario, L4M 7G1
Burlington Professional Centre
Burlington, Ontario, L7N 3V2
Urology Resource Centre
Burlington, Ontario, L7S 1V2
Dr. Allan Patrick Professional Corporation
Fredericton, New Brunswick, E3B 5B8
Hamilton District Urology Research Center
Hamilton, Ontario, L8N 4A6
Southern Interior Medical Research, Inc.
Kelowna, British Columbia, V1Y 2H4
Centre for Advanced Urological Research
Kingston, Ontario, K7L-2V7
London Region Cancer Program
London, Ontario, N6A 4L6
MOR Urology, Inc.
Newmarket, Ontario, L3X 1W1
Male Health Centres
Oakville, Ontario, L6H 3P1
Scarborough General Hospital, Medical Mall
Scarborough Village, Ontario, M1P 2T7
Andreou Research
Surrey, British Columbia, V3W 1N1
University Health Network - Princess Margaret Division
Toronto, Ontario, M5G 2M9
Dr. G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.
Read the detailed description
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study.
The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned. After stratification based on the patient's age, performance status, and severity of metastatic disease, the patients will be randomized at a 1:1 ratio to the following treatment arms:
- Daily oral risedronate combined with androgen deprivation
- Daily oral placebo combined with androgen deprivation
Initial clinical evaluation will be performed during the 2-week screening period. While patients receive per-protocol treatment, study assessments will be performed every 4 weeks during the first 3 months, and every 12 weeks thereafter.
Performance Status: Eastern Cooperative Oncology Group (ECOG) 0 to 2
Life Expectancy: At least 12 weeks
Hematopoietic:
- Absolute neutrophil count (ANC) > 1,000/mm3
- Platelet count > 100,000/mm3
- international normalized ratio (INR) < 1.5 x upper limit of normal unless on therapeutic anticoagulation
- Partial thromboplastin time (PTT) < 1.5 x upper limit of normal unless on therapeutic anticoagulation
Hepatic:
- Bilirubin < 1.5 mg/dL
- Alanine transaminase (ALT) < 2.5 x upper limit of normal
Renal:
- Creatinine clearance of > 30 mL/min (by Cockcroft-Gault)
Cardiovascular:
- No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure).
Pulmonary:
- Not specified
Calcium:
- Corrected serum calcium = (4.0 g/dL - actual albumin g/dL)x 0.8 + serum calcium
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Risedronate, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
Daily oral risedronate combined with androgen deprivation
PlaceboDrug
Daily oral placebo combined with androgen deprivation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Daily oral risedronate combined with androgen deprivation Receives: Drug: Risedronate |
| Placebo Arm | Placebo comparator | daily oral placebo combined with androgen deprivation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of SRE or Death Occurred Cumulatively
Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)
Measured: 36 months
Secondary outcomes (7)
Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL
Measured: 36 months
Time to Development of Hormone Refractory Disease
Measured: 36 months
Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)
Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24.
Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution.
The compounds are detected as a result of their natural fluorescence with a fluorescence detector
Measured: 24 weeks
Three- Year Survival Rate
Measured: 36 months
Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median
Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson \& Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson \& Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing.
The bound HRP conjugate is measured by a luminescent reaction.
Measured: 24 week
Bone Turnover Marker Changes-- Serum BAP
Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve
Measured: 24 week
Bone Turnover Marker Changes-- Serum Osteocalcin (OC)
Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration.
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionFeb 2008
- Study completionMar 2008
Why it stopped: Terminated due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Prostate CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Sweeney, MBBS
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Walther Cancer Institute, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Christopher Sweeney, MBBS, Hoosier Cancer Research Network
- Investigators
- Christopher Sweeney, M.B.B.S., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216060
- Sponsor's protocol ID
- HOG GU02-41
- Status last verified
- May 2016
- First submitted
- 13 Sep 2005
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
C. Sweeney, W. M. Dugan II, R. Dreicer, F. Chu, G. Parks, K. Baker, D. Reed, K. Jansz, J. Zadra, C. T. Yiannoutsos. J Clin Oncol 28, 2010 (suppl; abstr e15000)
Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.
PubMed 33270906Hahn NM, Yiannoutsos CT, Kirkpatrick K, Sharma J, Sweeney CJ. Failure to suppress markers of bone turnover on first-line hormone therapy for metastatic prostate cancer is associated with shorter time to skeletal-related event. Clin Genitourin Cancer. 2014 Feb;12(1):33-40.e4. doi: 10.1016/j.clgc.2013.07.002. Epub 2013 Oct 12.
PubMed 24126237
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41
- ClinicalTrials.gov ID
- NCT00216060
- Acronym / sponsor ID
- HOG GU02-41
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Christopher Sweeney, MBBSUniversity, hospital or other
- Collaborators
- Sanofi, Walther Cancer Institute, Hoosier Cancer Research Network
- Study start
- Oct 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.
Detailed description
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study.
The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned. After stratification based on the patient's age, performance status, and severity of metastatic disease, the patients will be randomized at a 1:1 ratio to the following treatment arms:
- Daily oral risedronate combined with androgen deprivation
- Daily oral placebo combined with androgen deprivation
Initial clinical evaluation will be performed during the 2-week screening period. While patients receive per-protocol treatment, study assessments will be performed every 4 weeks during the first 3 months, and every 12 weeks thereafter.
Performance Status: Eastern Cooperative Oncology Group (ECOG) 0 to 2
Life Expectancy: At least 12 weeks
Hematopoietic:
- Absolute neutrophil count (ANC) > 1,000/mm3
- Platelet count > 100,000/mm3
- international normalized ratio (INR) < 1.5 x upper limit of normal unless on therapeutic anticoagulation
- Partial thromboplastin time (PTT) < 1.5 x upper limit of normal unless on therapeutic anticoagulation
Hepatic:
- Bilirubin < 1.5 mg/dL
- Alanine transaminase (ALT) < 2.5 x upper limit of normal
Renal:
- Creatinine clearance of > 30 mL/min (by Cockcroft-Gault)
Cardiovascular:
- No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure).
Pulmonary:
- Not specified
Calcium:
- Corrected serum calcium = (4.0 g/dL - actual albumin g/dL)x 0.8 + serum calcium
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: RisedronateDaily oral risedronate combined with androgen deprivation |
| Placebo Arm | Placebo comparator | Drug: Placebodaily oral placebo combined with androgen deprivation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, MRI or bone scan) with plans to start or be < 30 days from beginning androgen deprivation therapy. Patients with lymph node or visceral metastases only are not eligible
- Patients may receive palliative radiation therapy at the investigators discretion during the first 4 weeks of beginning protocol therapy.
Key exclusion criteria (8 listed)
- No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing's disease).
- No use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates.
- No major surgery within 4 weeks of registration to protocol therapy.
- No adjuvant chemotherapy within 6 months of registration to protocol therapy.
- No previous chemotherapy for metastatic disease.
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 |
|---|---|---|
| RisedronateDaily oral risedronate combined with androgen deprivation | Drug | Experimental Arm |
| PlaceboDaily oral placebo combined with androgen deprivation | Drug | Placebo Arm |
Primary outcome
Numbers of SRE or Death Occurred Cumulatively
Time frame: 36 months
Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)
7 secondary outcomes
Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL
Time frame: 36 months
Time to Development of Hormone Refractory Disease
Time frame: 36 months
Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)
Time frame: 24 weeks
Three- Year Survival Rate
Time frame: 36 months
Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median
Time frame: 24 week
Bone Turnover Marker Changes-- Serum BAP
Time frame: 24 week
Bone Turnover Marker Changes-- Serum Osteocalcin (OC)
Time frame: 24 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationC. Sweeney, W. M. Dugan II, R. Dreicer, F. Chu, G. Parks, K. Baker, D. Reed, K. Jansz, J. Zadra, C. T. Yiannoutsos. J Clin Oncol 28, 2010 (suppl; abstr e15000)
- Derived from this study: PubMed 33270906Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.
- Derived from this study: PubMed 24126237Hahn NM, Yiannoutsos CT, Kirkpatrick K, Sharma J, Sweeney CJ. Failure to suppress markers of bone turnover on first-line hormone therapy for metastatic prostate cancer is associated with shorter time to skeletal-related event. Clin Genitourin Cancer. 2014 Feb;12(1):33-40.e4. doi: 10.1016/j.clgc.2013.07.002. Epub 2013 Oct 12.
- Individual participant dataSharing planned: No
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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.
Christopher Sweeney, M.B.B.S. study chair
Hoosier Oncology Group, LLC
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risedronate in people with Metastatic Prostate Cancer, run by Christopher Sweeney, MBBS at 45 sites in 2 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numbers of SRE or Death Occurred Cumulatively (time frame: 36 months). 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 NCT00216060, which also lists 3 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 26 May 2016.