NCT01397838UnknownPhase 1
Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
OsteoBuild Ltd.0 sites20 target enrollmentStarted: September 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Adverse events recorded throughout the study
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Pro-Bone
Experimental
Intervention: Pro-Bone (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Vital signs(4 weeks)
Investigators
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