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

NCT01397838 | Unknown Phase 1

• 1 other identifier: OBCS-001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenia

Keywords

Osteopenia

Outcome Measures

Primary Outcomes (2)

• Adverse events recorded throughout the study

  4 weeks

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

  4 weeks

Secondary Outcomes (1)

• Vital signs

  4 weeks

Study Arms (1)

Pro-Bone

EXPERIMENTAL

Drug: Pro-Bone

Interventions

Pro-Bone DRUG

500 mg Capsules of Pro-Bone twice daily

Pro-Bone

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• weeks or longer for any prior use of estrogen and/or progestin products.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OsteoBuild Ltd.: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Boris Kaplan, Prof.

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 20, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 20, 2011

Record last verified: 2011-07