Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
This study is not yet open for participant recruitment.
Verified July 2011 by OsteoBuild Ltd.
Information provided by:
First received: July 18, 2011
Last updated: July 19, 2011
Last verified: July 2011
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
Primary Outcome Measures:
- Adverse events recorded throughout the study [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Blood and urinalysis values assessed at pre-dose and according to study design. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Vital signs [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
500 mg Capsules of Pro-Bone twice daily
|Ages Eligible for Study:
||45 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397838
||Boris Kaplan, Prof.
||Rabin Medical Center
No publications provided
||Prof. Boris Kaplan, Rabin Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 18, 2011
||July 19, 2011
||Israel: Ministry of Health
Keywords provided by OsteoBuild Ltd.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Bone Diseases, Metabolic