Effect on bone turnover and Bone Mineral Density (BMD) of low dose oral silicon as an adjunct to calcium/vitamin D3 in a randomised, placebo-controlled trial

INTERVENTION: 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 different ch‐OSA doses (3, 6 and 12 drops) were used corresponding to 3, 6, and 12 mg Si. The placebo group was divided in 3 subgroups (3, 6, and 12 drops) to mimic the three different ch‐OSA dosages. The study medication was delivered in sealed 30 ml plastic bottles. The subjects were instructed to mix the ch‐OSA or placebo drops with 50 ml (2 floz, 1/4 glass) water or juice and to consume immediately, preferably 30 minutes before a meal or 2 hours after a meal. All subjects received calcium and vitamin D3 (Calcichew/D3 forte, Shire, UK) containing 1000 mg calcium and 20 mg cholecalciferol daily. 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 the safety parameters. Bone Mineral Density (BMD) was assessed by DEXA using a Hologic QDR 4500 W (Waltham, MA). Scans of the lumbar spine (L1 to L4) and femur (neck, trochanter, intertrochanteric area, Ward?s triangle and total) were performed at screening and/or at the inclusion visit and then after 12 months treatment at the final visit. Biochemical markers of bone formation (Osteocalcin [OC], Bone‐specific Alkaline Phosphatase [BAP], Procollagen type I N‐terminal Propeptide [PINP]) and bone resorption (Deoxypyridoline [DPD], C‐terminal telopeptide of type I collagen [CTX‐I]) were measured at baseline and after 6 and 12 months of treatment. CONDITION: Osteopenia ; Musculoskeletal Diseases ; Osteopenia PRIMARY OUTCOME: 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 OUTCOME: 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 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