Osteopenia Musculoskeletal Diseases Osteopenia
Conditions
Interventions
Subjects who meet the inclusion and exclusion criteria were randomly assigned to four groups to take by oral route choline-stabilized Orthosilicic Acid (ch-OSA) or a placebo daily for 12 months. Three
Sponsors
Bio Minerals N.V. (Belgium)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Osteopenic, but otherwise healthy 2. Caucasian women with a T-score less than -1.5 at the lumbar spine by Dual Energy X-ray Absorptiometry (DEXA) scan 3. Age range: mean age of 60.7 ± 10.4 years; gender of participants: female
Exclusion criteria
Exclusion criteria: Patients were excluded according to the following criteria: 1. Renal failure as defined by serum creatinine greater than 200 µmol/L 2. Abnormal serum ferritin level (normal range: 11 - 250 µg/L) 3. Concomitant medication (treatment with phosphate-binding antacids greater than 6 months/year) 4. Oral glucocorticoid treatment (greater than 8 months in the previous year and greater than 7.5 mg/day prednisone equivalent, or a total dose of more than 2 g prednisone equivalent in the previous 12 months) 5. Local injectable glucocorticoid treatment if greater than 5 injections per year 6. Inhaled glucocorticoid treatment if greater than 6 months in the previous year and more than 2 mg/day prednisone equivalent (glucocorticoids by local topical administration were not excluded) 7. Concomitant or previous treatment for bone diseases: 7.1. Fluoride salts: greater than 10 mg/day, for more than 2 weeks in the previous 12 months 7.2. Biphosphanates: for more than 2 weeks in the previous 12 months 7.3. Oral estrogens 7.4. Estradiol vaginal ring 7.5. Anti-estrogens 7.6. Progesterones 7.7. Anabolic steroids in the previous 3 months or used for more than 1 month in the previous 6 months 7.8. Estradiol implants in the previous 3 years 7.9. Ipriflavone use in the previous 6 months or used for more than 1 month in the previous 12 months 7.10. Calcitonin use in the previous month or used for more than 1 month in the previous 6 months 8. Other drugs for bone disease currently in development 9. Concomitant and previous use of food supplements containing silicon or horsetail herb extract, bamboo extract, colloidal silicic acid, or silanol derivatives in the previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The effect of oral ch-OSA on BMD, measured at baseline and after 12 months 2. The effect of oral ch-OSA on markers of bone turnover, measured at baseline and after 6 and 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ch-OSA related adverse events, measured at baseline and after 12 months treatment 2. Biochemical safety parameters of oral use of ch-OSA, measured at baseline and after 12 months treatment | — |
Countries
United Kingdom
Outcome results
None listed