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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01397838
• Other study ID #: OBCS-001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 18, 2011
• Last updated: July 19, 2011
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2011
• Source: OsteoBuild Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia

Intervention

Drug:
• Pro-Bone
500 mg Capsules of Pro-Bone twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OsteoBuild Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events recorded throughout the study		4 weeks	Yes
Primary	Blood and urinalysis values assessed at pre-dose and according to study design.		4 weeks	Yes
Secondary	Vital signs		4 weeks	Yes