Effects of D-003 and Omega-3 in women with osteoporosis
- Conditions
- Osteoporosis
- Registration Number
- RPCEC00000184
- Lead Sponsor
- atural Products Center/ National Center for Scientific Researchs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 50
1. Healthy female volunteers from common people.
2. Aged between 20 and 80 years old.
3. Surgically or naturally postmenopausal (defined as amenorrhea maintained for a period = 1 year).
4. Risk of osteoporosis moderate to high according to the scale of risk
5. Which have consented to give their informed consent.
1. Active liver disease, Active kidney disease, diagnosed Neoplasms or thyroid dysfunction.
2. Severe high blood pressure (90 mm Hg)
3. Uncompensated diabetes mellitus (fasting glucose> 7 mmol / L)
4.Consumption of hormone replacement therapy, bisphosphonates, anabolic steroids, calcitonin, sodium fluoride or corticosteroids in the 6 months prior to inclusion
5. The following values ??in laboratory tests: fasting glucose> 7 mmol / L; creatinine> 130 mol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 55 IU / L
6. History of acute myocardial infarction (AMI), surgical revascularization or cerebrovascular accident (CVA) (stroke) in the 6 months prior to inclusion.
7. Subjects with normal clinical history of drug allergy or any other special condition that endanger their health and their lives during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health Status Survey (Quality of Life Questionnaire Qualeffo-41. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks.
- Secondary Outcome Measures
Name Time Method