Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

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.

Official Title
-----------------
Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

Conditions
-----------------
Osteopenia

Intervention / Treatment
-----------------
* Drug: Pro-Bone


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pro-Bone<br> | Drug: Pro-Bone<br>* 500 mg Capsules of Pro-Bone twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events recorded throughout the study |  | 4 weeks | 
| Blood and urinalysis values assessed at pre-dose and according to study design. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteopenia