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临床试验/NCT00424619
NCT00424619已完成4 期

A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients

McMaster University0 个研究点目标入组 64 人开始时间: 2007年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
64
主要终点
25-hydroxyvitamin D3 (25-OHD)

研究概览

简要总结

The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture patients to achieve the optimal therapeutic level.

详细描述

Low Vitamin D levels can cause faster bone loss and increase the risk of having a fracture. Patients who experience a hip fracture have low levels of Vitamin D. It is not clear how much Vitamin D must be taken in order to reach this optimal level.

Serum 25-hydroxyvitamin D3 (25-OHD) concentrations are the recognized functional status indicator for vitamin D. Although there is no clear consensus, vitamin D 'insufficiency' has been considered in the range of 25- 75/80 nmol/L. Patients with acute hip fracture are at high risk for a recurrent hip fracture or other fragility fractures (and falls) and are a group who should be targeted for osteoporosis treatment (i.e. Bisphosphonate or other antiresorptive). Before fracture patients start on a bisphosphonate, however, an important consideration is whether 25-OHD levels are at a therapeutic level (>75 nmol/l and less than 150-200 nmol/L). Case-control studies indicate that older people who experience a hip fracture have lower serum concentrations of 25-OHD than do those without a fracture. In cross-sectional studies, the majority of patients with hip fracture are considered to have insufficient vitamin D levels. Although the benefits of supplementing patients with at least 800 to 1000 IU/day Vitamin D3 may be recognized, there is little information available to guide physicians regarding the appropriate management of hip fracture patients who may be severely Vitamin D deficient, particularly in acute hip fracture patients. Few studies have examined whether high dose vitamin D (i.e. 50,000 IU or greater/week) offers an advantage over smaller, routinely prescribed doses (i.e. 800 or 1000 IU), particularly in hip fracture patients.

The purpose of this study is to determine the number of hip fracture patients reaching an optimal level of vitamin D comparing between three different Vitamin D dose strategies:

A. 50,000 D2 oral bolus followed by 800 IU D3 daily B. 100,000 D2 oral bolus followed by 800 IU D3 daily C. 800 IU D3 daily

The Vitamin D strategies will be administered over 3-months in acute hip fracture patients. The proportion of patients reaching an optimal level of 25-OHD (>75 nmol/L) will be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fragility hip fracture patient
  • Previous Vitamin D supplementation is okay.

排除标准

  • Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease)
  • Cancer in the past 10 years likely to metastasize to bone
  • Renal insufficiency (creatinine <30 mls/min)
  • Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months
  • Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months
  • Pre-existing bone abnormality
  • Renal stones in past 10 years

研究组 & 干预措施

1

Active Comparator

50 000 IU Vitamin D2

干预措施: Vitamin D2 (Drug)

2

Active Comparator

100 000 IU Vitamin D2

干预措施: Vitamin D2 (Drug)

3

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

25-hydroxyvitamin D3 (25-OHD)

时间窗: Baseline, 4 weeks and 3 months

Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).

Parathyroid Hormone (PTH)

时间窗: Baseline

Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.

Calcium

时间窗: Baseline, 4 weeks

Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.

Phosphate

时间窗: Baseline

Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.

Alkaline Phosphatase

时间窗: Baseline

Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.

Hemoglobin

时间窗: Baseline

Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.

Creatinine

时间窗: Baseline

Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.

次要结局

  • Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months(3 months)
  • Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Papaioannou

Dr. Alexandra Papaioannou

McMaster University

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