Osteoporosis
Conditions
Interventions
Study Group: 2 tablets of D-003 (5 mg/d) + 1 capsule of Omega-3 (1g) by oral route to ingest once daily with food for 3 months.
Control group: 2 tablets of placebo+ 1 capsule of Omega-3 (1g) by oral r
Sponsors
Natural Products Center/ National Center for Scientific Researchs
Dalmer Laboratories
Eligibility
Sex/Gender
Female
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pain (qualeffo-41 questionnaire. Value between 0 and 100 points). Measuring time: At baseline, at the end of the 4, 8 and 12 weeks. Physical function (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Social function (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Health perception (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Mental function (qualeffo-41 questionnaire. Value between 0 and 100 points) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Physical Assessment (weight (kg), rate (beats / min), blood pressure (mm Hg)). Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. Blood chemistry parameters (total cholesterol (mmol / L), triglycerides (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L)). Measuring time:. At baseline, at the end of the12 weeks. Adverse events (description (name of event), intensity (mild, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated)) Measuring Time: At baseline, at the end of the 4, 8 and 12 weeks. | — |
Countries
Cuba
Contacts
Public ContactSarahi Mendoza Castaño
Center of Natural Productos, National Center for Scientific Research
Outcome results
None listed