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
- Conditions
- OsteopeniaMusculoskeletal Diseases
- Registration Number
- ISRCTN57103074
- Lead Sponsor
- Bio Minerals N.V. (Belgium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 184
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The effect of oral ch-OSA on BMD, measured at baseline and after 12 months<br>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
Name Time Method 1. Ch-OSA related adverse events, measured at baseline and after 12 months treatment<br>2. Biochemical safety parameters of oral use of ch-OSA, measured at baseline and after 12 months treatment