1. Osteopenia
Conditions
Interventions
A basic clinical examination was performed at each visit. Blood samples and single void urine samples were collected from fasting subjects at baseline and after 12 months supplementation to evaluate t
Sponsors
1. Twin Research and Genetic Epidemiology Unit, St Thomas’ Hospital, Kings College, London, United Kingdom;
2. Department of Pharmaceutical Sciences, Faculty of Pharmaceutical, Biomedical and Veterinary Sciences, University of Antwerp, Antwerp, Belgium;
3. MRC Human Nutrition Research, Elsie Widdowson Laboratory, Cambridge, United Kingdom.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Osteopenic, but otherwise healthy; 2. Caucasian women with a T-score < -1.5 at the lumbar spine by DEXA scan.
Exclusion criteria
Exclusion criteria: 1. Patients were excluded according to the following criteria: a. Renal failure as defined by serum creatinine > 200 µmol/L; b. Abnormal serum ferritin level (normal range: 11-250 µg/L); c. Concomitant medication (treatment with phosphate-binding antacids > 6 months / year); d. Oral glucocorticoid treatment (> 8 months in the previous year and > 7.5 mg/day prednisone equivalent, or a total dose of more than 2 g prednisone equivalent in the previous 12 months); e. Local injectable glucocorticoid treatment if > 5 injections per year; f. Inhaled glucocorticoid treatment if > 6 months in the previous year and more than 2 mg/day prednisone equivalent (glucocorticoids by local topical administration were not excluded); g. Concomitant or previous treatment for bone diseases (fluoride salts: > 10 mg/day, for more than 2 weeks in the previous 12 months; h. Biphosphanates: for more than 2 weeks in the previous 12 months; i. Oral estrogens; j. Estradiol vaginal ring; k. Anti-estrogens; l. Progesterones; m. Anabolic steroids in the previous 3 months or used for more than 1 month in the previous 6 months; n. Estradiol implants in the previous 3 years; o. Ipriflavone use in the previous 6 months or used for more than 1 month in the previous 12 months; p. Calcitonin use in the previous month or used for more than 1 month in the previous 6 months; q. Other drugs for bone disease currently in development); r. 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 choline-stabilized orthosilicic acid (ch-OSA) on markers of bone turnover and bone mineral density (BMD). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ch-OSA related adverse events; 2. Biochemical safety parameters of oral use of ch-OSA. | — |
Contacts
Public ContactMario Calomme
Department of Pharmaceutical Sciences Faculty of Pharmaceutical, Biomedical and Veterinary Sciences University of Antwerp Universiteitsplein 1
Outcome results
None listed