High Dosage Vitamin D and Osteoporosis - Full Text View

Sponsor:	University Hospital of North Norway
Collaborator:	Norske Kvinners Sanitetsforening Troms
Information provided by:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00491920

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Osteopenia	Drug: cholecalciferol (Vitamin D3) Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Calcium Minerals Osteoporosis

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	February 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

20 000 Iu x2/week

+ calcium 500 mg/cholecalciferol 400 IU x2/d

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

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491920

Locations

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

Sponsors and Collaborators

University Hospital of North Norway

Norske Kvinners Sanitetsforening Troms

Investigators

Principal Investigator:

Rolf Jorde, Ph.D, M.D

Medical Dpt, University Hospital of Northern Norway

More Information

No publications provided

Responsible Party:	University Hospital of North norway ( Rolf Jorde )
Study ID Numbers:	2006-003186-14
Study First Received:	June 25, 2007
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00491920 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:

osteoporosis
bone mineral density
vitamin D

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Cholecalciferol
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Bone Density Conservation Agents

Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions
Vitamin D
Musculoskeletal Diseases
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on February 09, 2010