High Dosage Vitamin D and Osteoporosis

Phase 4

Completed

• Conditions: Osteoporosis; Osteopenia

• Registration Number: NCT00491920
• Lead Sponsor: University Hospital of North Norway

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-02
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 297

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
changes in bone mineral density in columna and total hip.	One year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Dpt. B, University Hospital of Northern Norway; 🇳🇴 Tromsø, Norway