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

This study has been completed.
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier:
NCT00424619
First received: January 17, 2007
Last updated: May 11, 2012
Last verified: May 2012

January 17, 2007
May 11, 2012
October 2007
July 2009   (final data collection date for primary outcome measure)
  • 25-hydroxyvitamin D3 (25-OHD) [ Time Frame: Baseline, 4 weeks and 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.
  • Calcium [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.
  • Phosphate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.
  • Alkaline Phosphatase [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.
  • Hemoglobin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.
  • Creatinine [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.
  • Baseline bloodwork for 25-OHD, PTH, Calcium, Phosphate, Alkaline Phosphatase, CBC with automated differential, Creatine
  • 25-OHD and Calcium at 4 weeks
  • 25-OHD at 3 months
Complete list of historical versions of study NCT00424619 on ClinicalTrials.gov Archive Site
  • Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): "Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again". Scores are measured as time in seconds to complete the task.
  • Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres.
  • Functional assessment using the Timed Up & Go Test at admission and discharge
  • Functional assessment using the 2 Minute Walk Test at admission and discharge
Not Provided
Not Provided
 
A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients

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.

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.

Secondary measures include the Timed Up and Go test, and 2 Minute Walk Test to compare the effects of the Vitamin D supplementation strategies on functional and muscle strength scales.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hip Fracture
  • Drug: Vitamin D2
    50 000 IU vitamin D2, one time bolus dose
    Other Name: Ostoforte
  • Drug: Vitamin D2
    100 000 IU vitamin D2, one time bolus dose
    Other Name: Ostoforte
  • Drug: Placebo
    Placebo, 1 time bolus dose
    Other Name: Placebo
  • Active Comparator: 1
    50 000 IU Vitamin D2
    Intervention: Drug: Vitamin D2
  • Active Comparator: 2
    100 000 IU Vitamin D2
    Intervention: Drug: Vitamin D2
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
Papaioannou A, Kennedy CC, Giangregorio L, Ioannidis G, Pritchard J, Hanley DA, Farrauto L, DeBeer J, Adachi JD. A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: no advantage of loading doses over daily supplementation. BMC Musculoskelet Disord. 2011 Jun 20;12:135.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00424619
06-449, P1975
No
Alexandra Papaioannou, McMaster University
Hamilton Health Sciences Corporation
Merck Frosst Canada Ltd.
Principal Investigator: Alexandra Papaioannou, M.D., M.Sc. McMaster University
McMaster University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP