Status:
UNKNOWN
Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
Lead Sponsor:
OsteoBuild Ltd.
Conditions:
Osteopenia
Eligibility:
FEMALE
45-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01397838
Start Date
September 1 2011
End Date
January 1 2012
Last Update
July 20 2011
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