Osteopenia
Conditions
Keywords
Osteopenia
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.
Interventions
DRUGPro-Bone
500 mg Capsules of Pro-Bone twice daily
Sponsors
OsteoBuild Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
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: 1. 8 weeks or longer for any prior use of estrogen and/or progestin products. 2. 6 months or longer for prior progestin injectable drug therapy. 3. Women between 45 and 65 years (inclusive) of age. 4. BMI 22-30 (inclusive) 5. Non-smoking (by declaration) for a period of at least 6 months. 6. 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Vital signs | 4 weeks |
Outcome results
None listed