Risk of Bone Fracture OccurrencesPhase 3TREAT2NCT01214291
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer
A Phase 3 study testing Toremifene in people with Risk of Bone Fracture Occurrences, run by GTx at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Risk of Bone Fracture Occurrences
- What is being tested?
- Toremifene
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2011
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- give voluntary signed informed consent
- have histologically documented prostate cancer
- have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months
- expected to continue LHRHa therapy uninterrupted for the next 12 months
- have total testosterone levels less than 50 ng/dL
- Have BMD of lumbar spine or femoral neck at or below the BMD thresholds
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- have a Zubrod performance status <or equal to 1
- subject weight <300 lbs(<136 kg)
- agree to complete a daily diary of medication intake
- agree not to take excluded medications throughout the trial
- agree to use an effective method of contraception
- have adequate bone marrow, liver and renal functions
Who cannot join
- Currently or previously exposed
- within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab
- for more than 3 years to oral bisphosphonates
- within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids
- have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine
- have <8 evaluable vertebrae
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- have a BMD T score <-4 at the lumbar spine or total hip or femoral neck
- have any history of other carcinomas within the last 5 years
- Serum PSA > 5ng/mL at baseline under ADT
- have Paget's disease, Cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis
- have active uncontrolled systemic viral, bacterial or fungal infections
- have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance
- received treatment with other investigational agents within 30 days
- taking finasteride, dutasteride, danazol or testosterone like substances
- taking herbal medicines or dietary supplements
- have a history of thromboembolic disease including DVT or pulmonary embolus
- have a QTcF of > or equal to 450 msec or congenital or acquired QTc prolongation
- have HIV
- calcicum urolithiasis prohibiting the use of vitamin D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate 80 mg for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer on Androgen Deprivation Therapy
The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.
- Conditions
- Risk of Bone Fracture Occurrences
- Being tested
- Toremifene
- Keywords
- fractures, prostate cancer, androgen deprivation therapy
- Medical subject headings
- Fractures, Bone, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToremifeneDrug
Toremifene 80mg daily
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the efficacy of toremifene 80mg compared with placebo in the reduction in the risk of new bone fracture occurrences in men with prostate cancer on androgen deprivation therapy as measured by semiquantitative assessment of vertebral fractures
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: cost of conducting the study and increased burden on the clinical trial professionals make it impossible for us to proceed with the development of the drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of Bone Fracture OccurrencesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Mitchell Steiner, MD, Study director, GTx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214291
- Sponsor's protocol ID
- G300213
- Acronym
- TREAT2
- Status last verified
- Nov 2013
- First submitted
- 1 Oct 2010
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate 80 mg for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer on Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01214291
- Acronym / sponsor ID
- TREAT2 / G300213
- Conditions
- Risk of Bone Fracture Occurrences
- Keywords
- fractures, prostate cancer, androgen deprivation therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: cost of conducting the study and increased burden on the clinical trial professionals make it impossible for us to proceed with the development of the drug.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Collaborators
- Ipsen
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Oct 2010 (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 determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- give voluntary signed informed consent
- have histologically documented prostate cancer
- have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months
- expected to continue LHRHa therapy uninterrupted for the next 12 months
- have total testosterone levels less than 50 ng/dL
Key exclusion criteria (19 listed)
- Currently or previously exposed
- within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab
- for more than 3 years to oral bisphosphonates
- within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids
- have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine
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 |
|---|---|---|
| ToremifeneToremifene 80mg daily | Drug | – |
Primary outcome
To confirm the efficacy of toremifene 80mg compared with placebo in the reduction in the risk of new bone fracture occurrences in men with prostate cancer on androgen deprivation therapy as measured by semiquantitative assessment of vertebral fractures
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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.
Mitchell Steiner, MD study director
GTx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toremifene in people with Risk of Bone Fracture Occurrences, run by GTx at 1 site 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 12 inclusion and 19 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: withdrawn, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 was withdrawn before enrolling participants, so there are no results.
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 confirm the efficacy of toremifene 80mg compared with placebo in the reduction in the risk of new bone fracture occurrences in men with prostate cancer on androgen deprivation therapy as measured by semiquantitative assessment of vertebral fractures (time frame: 36 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 15 Nov 2013.