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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

Resource links provided by NLM:

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 ]

Enrollment: 297
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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
ClinicalTrials.gov Identifier: NCT00491920     History of Changes
Other Study ID Numbers: 2006-003186-14
Study First Received: June 25, 2007
Last Updated: November 2, 2011
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:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013