High Dosage Vitamin D and Osteoporosis

Study Overview
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Brief Summary
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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.

Official Title
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High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Drug: cholecalciferol (Vitamin D3)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in bone mineral density in columna and total hip. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength (hand grip strength and knee extension) |  | One year | 
| balance (tandem test) |  | One year | 
| body composition (Dexa) |  | One year | 
| inflammation markers |  | One year | 
| calcium and vitamin D metabolism |  | One year | 
| blood lipids |  | One year | 
| renal function |  | One year | 
| telomere length |  | one year | 
| perception of own health |  | one year | 
| Urinary tract symptoms |  | one year | 
| effects of polymorphisms in VDR on the other endpoints |  | one year | 
| side effects |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, bone mineral density, vitamin D