Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
n° 00/1
Study information
Scientific title
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
Acronym
Study hypothesis
To investigate the effect of low dose oral silicon as an adjunct to calcium/vitamin D3 on markers of bone turnover and BMD.
Ethics approval
Ethics approval received from St Thomas Hospital Local Research Ethics Committee on the 20th March 2001 (ref: EC01/009).
Study design
Double blind, placebo controlled randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Osteopenia
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, Wards 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.
Intervention type
Supplement
Phase
Not Specified
Drug names
Silicon, calcium, vitamin D3 supplementation
Primary outcome measures
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 measures
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
Overall trial start date
01/06/2001
Overall trial end date
01/02/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
184
Participant 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
Recruitment start date
01/06/2001
Recruitment end date
01/02/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Twin Research and Genetic Epidemiology Unit
London
SE1 7EH
United Kingdom
Funders
Funder type
Charity
Funder name
National Osteoporosis Society (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18547426
Publication citations
-
Results
Spector TD, Calomme MR, Anderson SH, Clement G, Bevan L, Demeester N, Swaminathan R, Jugdaohsingh R, Berghe DA, Powell JJ, 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., BMC Musculoskelet Disord, 2008, 9, 85, doi: 10.1186/1471-2474-9-85.