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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 02, 2014