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

OsteoBuild

Status and phase

Unknown

Phase 1

Conditions

Osteopenia

Treatments

Drug: Pro-Bone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01397838

OBCS-001

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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.