High Dosage Vitamin D and Osteoporosis

This study has been completed.

Sponsor:

Collaborator:

Norske Kvinners Sanitetsforening Troms

Information provided by (Responsible Party):

University Hospital of North Norway

ClinicalTrials.gov Identifier:

NCT00491920

First received: June 25, 2007

Last updated: November 2, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2007

Last Updated Date

November 2, 2011

Start Date ^ICMJE

February 2007

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

changes in bone mineral density in columna and total hip. [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

changes in bone mineral density in columna and total hip. [ Time Frame: One year ]

Change History

Complete list of historical versions of study NCT00491920 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Muscle strength (hand grip strength and knee extension) [ Time Frame: One year ] [ Designated as safety issue: No ]
balance (tandem test) [ Time Frame: One year ] [ Designated as safety issue: No ]
body composition (Dexa) [ Time Frame: One year ] [ Designated as safety issue: No ]
inflammation markers [ Time Frame: One year ] [ Designated as safety issue: No ]
calcium and vitamin D metabolism [ Time Frame: One year ] [ Designated as safety issue: Yes ]
blood lipids [ Time Frame: One year ] [ Designated as safety issue: No ]
renal function [ Time Frame: One year ] [ Designated as safety issue: Yes ]
telomere length [ Time Frame: one year ] [ Designated as safety issue: No ]
perception of own health [ Time Frame: one year ] [ Designated as safety issue: No ]
Urinary tract symptoms [ Time Frame: one year ] [ Designated as safety issue: No ]
effects of polymorphisms in VDR on the other endpoints [ Time Frame: one year ] [ Designated as safety issue: No ]
side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Muscle strength (hand grip strength and knee extension) [ Time Frame: One year ]
balance (tandem test) [ Time Frame: One year ]
body composition (Dexa) [ Time Frame: One year ]
inflammation markers [ Time Frame: One year ]
calcium and vitamin D metabolism [ Time Frame: One year ]
blood lipids [ Time Frame: One year ]
renal function [ Time Frame: One year ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

High Dosage Vitamin D and Osteoporosis

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis
Osteopenia

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

297

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00491920

Other Study ID Numbers ^ICMJE

2006-003186-14

Has Data Monitoring Committee

Responsible Party

University Hospital of North Norway

Study Sponsor ^ICMJE

University Hospital of North Norway

Collaborators ^ICMJE

Norske Kvinners Sanitetsforening Troms

Investigators ^ICMJE

Principal Investigator:

Rolf Jorde, Ph.D, M.D

Medical Dpt, University Hospital of Northern Norway

Information Provided By

University Hospital of North Norway

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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