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

• Status: Unknown status
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OsteoBuild Ltd.

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:

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.