Choline-stabilized orthosilicic acid supplementation as an adjunct to calcium/vitamin D3 stimulates markers of bone formation in osteopenic females: a randomized, placebo-controlled trial.
BACKGROUND
Mounting evidence supports a physiological role for silicon (Si) as orthosilicic acid (OSA, Si(OH)4) in bone formation. The effect of oral choline-stabilized orthosilicic acid (ch-OSA) on markers of bone turnover and bone mineral density (BMD) was investigated in a double-blind placebo-controlled trial.


METHODS
Over 12-months, 136 women out of 184 randomized (T-score spine < -1.5) completed the study and received, daily, 1000 mg Ca and 20 microg cholecalciferol (Vit D3) and three different ch-OSA doses (3, 6 and 12 mg Si) or placebo. Bone formation markers in serum and urinary resorption markers were measured at baseline, and after 6 and 12 months. Femoral and lumbar BMD were measured at baseline and after 12 months by DEXA.


RESULTS
Overall, there was a trend for ch-OSA to confer some additional benefit to Ca and Vit D3 treatment, especially for markers of bone formation, but only the marker for type I collagen formation (PINP) was significant at 12 months for the 6 and 12 mg Si dose (vs. placebo) without a clear dose response effect. A trend for a dose-corresponding increase was observed in the bone resorption marker, collagen type I C-terminal telopeptide (CTX-I). Lumbar spine BMD did not change significantly. Post-hoc subgroup analysis (baseline T-score femur < -1) however was significant for the 6 mg dose at the femoral neck (T-test). There were no ch-OSA related adverse events observed and biochemical safety parameters remained within the normal range.


CONCLUSIONS
Combined therapy of ch-OSA and Ca/Vit D3 had a potential beneficial effect on bone collagen compared to Ca/Vit D3 alone which suggests that this treatment is of potential use in osteoporosis. NTR 1029.
Spector
Tim D
TD
Twin Research and Genetic Epidemiology Unit, St Thomas' Hospital, Kings College, London, UK. tim.spector@kcl.ac.uk
Calomme
Mario R
MR
Anderson
Simon H
SH
Clement
Gail
G
Bevan
Liisa
L
Demeester
Nathalie
N
Swaminathan
Rami
R
Jugdaohsingh
Ravin
R
Berghe
Dirk A Vanden
DA
Powell
Jonathan J
JJ
D000368:Aged; D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001851:Bone Diseases, Metabolic / Q000188:drug therapy* / Q000378:metabolism; D002118:Calcium / Q000008:administration & dosage* / Q000009:adverse effects; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects; D002794:Choline / Q000008:administration & dosage / Q000009:adverse effects; D003094:Collagen / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D017698:Postmenopause; D012824:Silicic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D010919:Placebos; D012824:Silicic Acid; D002762:Cholecalciferol; D003094:Collagen; D002794:Choline; D002118:Calcium