Bone Mineral Density (BMD) Musculoskeletal Diseases Bone Mineral Density (BMD)
Conditions
Interventions
Current intervention as of 20/05/2022:
Participants are assigned to the following intervention groups:
Intervention 1: Control group with water for 2 years (ERB-C).
Sponsors
CIBER (Consorcio Centro de Investigación Biomédica en Red, M.P.)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 20/05/2022: 1. Postmenopausal women between 45 and 70 years of age 2. FSH 23-116 U/l 3. Estradiol (E2) 3 Miu/mL 3. Estradiol (E2) = 30 pg/mL 4. Amenorrhea = 12 months
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 08/08/2022: 1. Patients with known diseases affecting bone metabolism (rheumatoid arthritis, hyperthyroidism, hypercortisolism, renal bone disease, chronic liver disease, among others) 2. Use of drugs affecting bone metabolism (fluorides, bisphosphonates, calcitonin, teriparatide or parathormone, strontium ranelate, SERMs, estrogen therapy, anabolic steroids, chronic glucocorticoids (>3 months), cytostatics, antiandrogens, and antiepileptics) 3. Participants who received silicon or polyphenol supplements Previous participant exclusion criteria as of 20/05/2022: 1. Patients with known diseases affecting bone metabolism (rheumatoid arthritis, hyperthyroidism, hypercortisolism, renal bone disease, chronic liver disease, among others) 2. Participants who received silicon or polyphenol supplements Previous participant exclusion criteria: 1. Patients with known diseases affecting bone metabolism (rheumatoid arthritis, hyperthyroidism, surgical menopause, hypercortisolism, renal bone disease, chronic liver disease, among others) 2. Use of drugs affecting bone metabolism (fluorides, bisphosphonates, calcitonin, teriparatide or parathormone, strontium ranelate, SERMs, estrogen therapy, anabolic steroids, chronic glucocorticoids (> 3 months), cytostatics, antiandrogens and antiepileptics) 3. Participants who received silicon or polyphenol supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bone mineral density is measured using the dual energy X-ray absorptiometry (DXA) at baseline, 1 year and at the end of the intervention period 2. Trabecular bone score (TBS) at lumbar spine is measured using the DXA at baseline, 1 year and at the end of the intervention period 3. Volumetric dual-energy X-ray absorptiometry (3D-DXA) at the proximal femur is measured using 3D-DXA at baseline, 1 year and at the end of the intervention period 4. Markers of bone formation (serum PINP and bone AP concentrations) and bone resorption (s-CTX and u-NTX concentrations) are measured by ELISA and electrochemiluminiscence, CrossLaps ELISA and ELISA Ostex, respectively, at baseline, 6 months, 1 year and at the end of the intervention period 5. Molecular mediators of bone turnover, namely sclerostin and Dkk-1 are measured using a newly developed ELISA (Biochemical GMBH) at baseline, 6 months, 1 year and at the end of the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At the beginning, 6 months, 1 year and at the end of each intervention period a medical assessment will be performed which included: clinical history (personal questionnaire), anthropometric measurements (measured using stand-alone stadiometer and a tape measure), clinical blood pressure (measured using and electronic pressure Omron apparatus) and full blood analysis (glucose, glycated hemoglobin, triglycerids, total cholesterol, HDLc, LDLc, lipoprotein (a), creatinine, calcium, phosphatase, PTH, 25OHD measured using blood samples) and the collection of 24-h urine samples 2. Dietary evaluation: nutrient intake and adherence to dietary recommendations is measured using a 7-day food record validated nutritional questionnaire and a Food Frequency test at baseline, six months, one year and at the end of the interventions 3. Physical activity is measured using the Minnesota Leisure Time Physical Activity questionnaire at baseline, six months, one year and at the end of the intervention period 4. Bioavailability, identification and quantification polyphenols in biological samples is measured using LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS at baseline and at the end of the intervention period 5. Changes in urine metabolites is measured using mass spectrometry and statistical analysis at baseline and at the end of the intervention period | — |
Countries
Spain
Outcome results
None listed