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

Bio Minerals N.V. (Belgium)0 sites184 target enrollmentJanuary 7, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 7, 2008

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

Female

Sponsor

Bio Minerals N.V. (Belgium)

•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