High Dosage Vitamin D and Osteoporosis

November 2, 2011 updated by: University Hospital of North Norway

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

297

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Tromsø, Norway, 9012
    - Medical Dpt. B, University Hospital of Northern Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

Norske Kvinners Sanitetsforening Troms

Investigators

Principal Investigator: Rolf Jorde, Ph.D, M.D, Medical Dpt, University Hospital of Northern Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)