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High Dosage Vitamin D and Osteoporosis

Primary Purpose

Osteoporosis, Osteopenia

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
cholecalciferol (Vitamin D3)
placebo
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, bone mineral density, vitamin D

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical Dpt. B, University Hospital of Northern Norway

Outcomes

Primary Outcome Measures

changes in bone mineral density in columna and total hip.

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2007
Last Updated
November 2, 2011
Sponsor
University Hospital of North Norway
Collaborators
Norske Kvinners Sanitetsforening Troms
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1. Study Identification

Unique Protocol Identification Number
NCT00491920
Brief Title
High Dosage Vitamin D and Osteoporosis
Official Title
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Norske Kvinners Sanitetsforening Troms

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
osteoporosis, bone mineral density, vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cholecalciferol (Vitamin D3)
Intervention Description
20 000 Iu x2/week + calcium 500 mg/cholecalciferol 400 IU x2/d
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
Primary Outcome Measure Information:
Title
changes in bone mineral density in columna and total hip.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Muscle strength (hand grip strength and knee extension)
Time Frame
One year
Title
balance (tandem test)
Time Frame
One year
Title
body composition (Dexa)
Time Frame
One year
Title
inflammation markers
Time Frame
One year
Title
calcium and vitamin D metabolism
Time Frame
One year
Title
blood lipids
Time Frame
One year
Title
renal function
Time Frame
One year
Title
telomere length
Time Frame
one year
Title
perception of own health
Time Frame
one year
Title
Urinary tract symptoms
Time Frame
one year
Title
effects of polymorphisms in VDR on the other endpoints
Time Frame
one year
Title
side effects
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Jorde, Ph.D, M.D
Organizational Affiliation
Medical Dpt, University Hospital of Northern Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Dpt. B, University Hospital of Northern Norway
City
Tromsø
ZIP/Postal Code
9012
Country
Norway

12. IPD Sharing Statement

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High Dosage Vitamin D and Osteoporosis

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