High Dosage Vitamin D and Osteoporosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-02-28

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.

Detailed Description

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Conditions

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Osteoporosis Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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cholecalciferol (Vitamin D3)

20 000 Iu x2/week

\+ calcium 500 mg/cholecalciferol 400 IU x2/d

Intervention Type DRUG

placebo

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

Intervention Type DRUG

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Jorde, Ph.D, M.D

Role: PRINCIPAL_INVESTIGATOR

Medical Dpt, University Hospital of Northern Norway

Locations

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Medical Dpt. B, University Hospital of Northern Norway

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2006-003186-14

Identifier Type: -

Identifier Source: org_study_id