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

Primary Purpose

Osteopenia

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Pro-Bone

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring Osteopenia

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pro-Bone

Arm Description

Outcomes

Primary Outcome Measures

Adverse events recorded throughout the study

Blood and urinalysis values assessed at pre-dose and according to study design.

Secondary Outcome Measures

Vital signs

Full Information

NCT ID

NCT01397838

First Posted

July 18, 2011

Last Updated

July 19, 2011

Sponsor

OsteoBuild Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01397838

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

OsteoBuild Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia

Keywords

Osteopenia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pro-Bone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pro-Bone

Intervention Description

500 mg Capsules of Pro-Bone twice daily

Primary Outcome Measure Information:

Title

Adverse events recorded throughout the study

Time Frame

4 weeks

Title

Blood and urinalysis values assessed at pre-dose and according to study design.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Vital signs

Time Frame

4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris Kaplan, Prof.

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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