Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by OsteoBuild Ltd..
Recruitment status was Not yet recruiting
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 20, 2014
Bone Diseases, Metabolic