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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01397838 |
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Date of registration:
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18/07/2011 |
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Primary sponsor: |
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Public title:
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Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
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Scientific title:
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Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01397838 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Contacts
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Name:
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Boris Kaplan, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rabin Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
45 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteopenia
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Intervention(s)
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Drug: Pro-Bone
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Primary Outcome(s)
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Adverse events recorded throughout the study
[Time Frame: 4 weeks]
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Blood and urinalysis values assessed at pre-dose and according to study design.
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Vital signs
[Time Frame: 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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