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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by OsteoBuild Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
OsteoBuild Ltd.
ClinicalTrials.gov Identifier:
NCT01397838
First received: July 18, 2011
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Osteopenia
Drug: Pro-Bone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

Resource links provided by NLM:


Further study details as provided by OsteoBuild Ltd.:

Primary Outcome Measures:
  • Adverse events recorded throughout the study [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Blood and urinalysis values assessed at pre-dose and according to study design. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vital signs [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pro-Bone Drug: Pro-Bone
500 mg Capsules of Pro-Bone twice daily

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397838

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

No publications provided

Responsible Party: Prof. Boris Kaplan, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01397838     History of Changes
Other Study ID Numbers: OBCS-001
Study First Received: July 18, 2011
Last Updated: July 19, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by OsteoBuild Ltd.:
Osteopenia

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

ClinicalTrials.gov processed this record on August 28, 2014