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

July 19, 2011 updated by: OsteoBuild Ltd.

Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pro-Bone
Drug: Pro-Bone
500 mg Capsules of Pro-Bone twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events recorded throughout the study
Time Frame: 4 weeks
4 weeks
Blood and urinalysis values assessed at pre-dose and according to study design.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OsteoBuild Ltd.

Investigators

  • Principal Investigator: Boris Kaplan, Prof., Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBCS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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