OsteopeniaPhase 1NCT01397838
Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
A Phase 1 study testing Pro-Bone in people with Osteopenia, run by OsteoBuild Ltd..
Trial summary
Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- Pro-Bone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 1
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMD as measured by DEXA at screening, should range between (-1)to (-2.5) SD from normal values.
- At least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Study participants not taking estrogen alone or estrogen/progestin containing drug products.
- Study participants not taking any anti-osteoporosis treatment for at list one year.
- The following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products:
- 8 weeks or longer for any prior use of estrogen and/or progestin products.
Show all 12Show fewer
- 6 months or longer for prior progestin injectable drug therapy.
- Women between 45 and 65 years (inclusive) of age.
- BMI 22-30 (inclusive)
- Non-smoking (by declaration) for a period of at least 6 months.
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects who provide written informed consent.
Who cannot join
- Women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies.
- Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- Any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit.
- Known history of drug or alcohol abuse according to participant declaration at screening visit.
- Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- Subjects who are non-cooperative or unwilling to sign consent form.
About this study
Official title: Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone.
- Conditions
- Osteopenia
- Being tested
- Pro-Bone
- Keywords
- Osteopenia
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-BoneDrug
500 mg Capsules of Pro-Bone twice daily
| Study group | Role | What they receive |
|---|---|---|
| Pro-Bone | Experimental | Not described Receives: Drug: Pro-Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events recorded throughout the study
Measured: 4 weeks
Blood and urinalysis values assessed at pre-dose and according to study design.
Measured: 4 weeks
Secondary outcomes (1)
Vital signs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OsteoBuild Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boris Kaplan, Prof., Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397838
- Sponsor's protocol ID
- OBCS-001
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
- ClinicalTrials.gov ID
- NCT01397838
- Acronym / sponsor ID
- OBCS-001
- Conditions
- Osteopenia
- Keywords
- Osteopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- OsteoBuild Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 20 Jul 2011 (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.
Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pro-Bone | Experimental | Drug: Pro-Bone |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- BMD as measured by DEXA at screening, should range between (-1)to (-2.5) SD from normal values.
- At least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Study participants not taking estrogen alone or estrogen/progestin containing drug products.
- Study participants not taking any anti-osteoporosis treatment for at list one year.
- The following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products:
Key exclusion criteria (6 listed)
- Women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies.
- Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- Any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit.
- Known history of drug or alcohol abuse according to participant declaration at screening visit.
- Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
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 |
|---|---|---|
| Pro-Bone500 mg Capsules of Pro-Bone twice daily | Drug | Pro-Bone |
Primary outcome
Adverse events recorded throughout the study
Time frame: 4 weeks
Blood and urinalysis values assessed at pre-dose and according to study design.
Time frame: 4 weeks
1 secondary outcome
Vital signs
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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.
Boris Kaplan, Prof. principal investigator
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pro-Bone in people with Osteopenia, run by OsteoBuild Ltd..
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 6 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Adverse events recorded throughout the study (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 20 Jul 2011.