Condition category
Musculoskeletal Diseases
Date applied
05/12/2007
Date assigned
07/01/2008
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tim Spector

ORCID ID

Contact details

Twin Research and Genetic Epidemiology Unit
St Thomas' Hospital
Kings College
London
SE1 7EH
United Kingdom

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, 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.

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

Sponsor information

Organisation

Bio Minerals N.V. (Belgium)

Sponsor details

Zenderstraat 12
Destelbergen
9070
Belgium

Sponsor type

Industry

Website

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

  1. 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.

Additional files

Editorial Notes