Trial | NCT00491920  Report issue

Title

High Dosage Vitamin D and Osteoporosis
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    297
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.
Study Started
Feb 28
2007
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Nov 03
2011
Estimate

Drug cholecalciferol (Vitamin D3)

20 000 Iu x2/week + calcium 500 mg/cholecalciferol 400 IU x2/d

Drug placebo

Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w

Criteria 

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
No Results Posted