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Completed

NCT Number: NCT00491920

High Dosage Vitamin D and Osteoporosis

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical Dpt. B, University Hospital of Northern Norway

Tromsø, 9012, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cholecalciferol (vitamin D3)

Drug

20 000 Iu x2/week

+ calcium 500 mg/cholecalciferol 400 IU x2/d

Placebo

Drug

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

Primary outcomes

  1. changes in bone mineral density in columna and total hip.

    Time frame: One year

Secondary outcomes

  1. Muscle strength (hand grip strength and knee extension)

    Time frame: One year

  2. balance (tandem test)

    Time frame: One year

  3. body composition (Dexa)

    Time frame: One year

  4. inflammation markers

    Time frame: One year

  5. calcium and vitamin D metabolism

    Time frame: One year

  6. blood lipids

    Time frame: One year

  7. renal function

    Time frame: One year

  8. telomere length

    Time frame: one year

  9. perception of own health

    Time frame: one year

  10. Urinary tract symptoms

    Time frame: one year

  11. effects of polymorphisms in VDR on the other endpoints

    Time frame: one year

  12. side effects

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Norske Kvinners Sanitetsforening Troms

Registry information

Official study title

High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 26, 2007
Registry last updated
Nov 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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