High Dosage Vitamin D and Osteoporosis

University Hospital of North Norway

Status and phase

Completed

Phase 4

Conditions

Osteopenia

Osteoporosis

Treatments

Drug: cholecalciferol (Vitamin D3)

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00491920

2006-003186-14

Details and patient eligibility

About

Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.

Enrollment

297 patients

Sex

Female

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

bone mineral density in L2-4 or mean total hip with T-score <= -2.0

Exclusion criteria

current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year
serum creatinin >110 umol/L
systolic blood pressure >175 mmHg or diastolic blod pressure >105
serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)
kidney stone
serum calcium > 2.55 mmol/L
suspect primary hyperparathyroidism with serum calcium >2.50 mmol/L combined with PTH > 5.0 mmol/L or serum calcium > 2.45 mmol/L combined with PTH >= 7.0 pmol/L