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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397838
Recruitment Status : Unknown
Verified July 2011 by OsteoBuild Ltd..
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Information provided by:
OsteoBuild Ltd.

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 Pro-bone.

Condition or disease Intervention/treatment Phase
Osteopenia Drug: Pro-Bone Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
Study Start Date : September 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Pro-Bone Drug: Pro-Bone
500 mg Capsules of Pro-Bone twice daily

Primary Outcome Measures :
  1. Adverse events recorded throughout the study [ Time Frame: 4 weeks ]
  2. Blood and urinalysis values assessed at pre-dose and according to study design. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Vital signs [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397838

Sponsors and Collaborators
OsteoBuild Ltd.
Principal Investigator: Boris Kaplan, Prof. Rabin Medical Center

Responsible Party: Prof. Boris Kaplan, Rabin Medical Center Identifier: NCT01397838     History of Changes
Other Study ID Numbers: OBCS-001
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by OsteoBuild Ltd.:

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases