Risks and benefits of moderate beer intake (with and without alcohol) on osteoporosis in postmenopausal wome

Not Applicable

Completed

• Conditions: Bone Mineral Density (BMD); Musculoskeletal Diseases

• Registration Number: ISRCTN13825020
• Lead Sponsor: CIBER (Consorcio Centro de Investigación Biomédica en Red, M.P.)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36458171/ (added 06/04/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37402233/ Effect on cardiovascular health (added 05/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-02
• Study Completion: 2021-08-31
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 37

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) <37 pg/ml
4. Amenorrhea =12 months

Previous participant inclusion criteria:
1. Women between 45 and 70 years of age within 5 years of menopause
2. FSH > 3 Miu/mL
3. Estradiol (E2) = 30 pg/mL
4. Amenorrhea = 12 months

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified