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A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
This study is currently recruiting participants.
Verified by McMaster University, January 2009
First Received: January 17, 2007   Last Updated: January 8, 2009   History of Changes
Sponsors and Collaborators: Hamilton Health Sciences
Merck Frosst Canada Ltd.
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00424619
  Purpose

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.


Condition Intervention Phase
Acute Hip Fracture Patients
Drug: Vitamin D2
Drug: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment
Official Title: A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Baseline bloodwork for 25-OHD, PTH, Calcium, Phosphate, Alkaline Phosphatase, CBC with automated differential, Creatine [ Time Frame: 4 weeks and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional assessment using the 2 Minute Walk Test and Timed up and Go (TUG) at discharge and 3 month follow up [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: October 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
50 000 IU Vitamin D2
Drug: Vitamin D2
50 000 IU vitamin D2, one time bolus dose
2: Active Comparator
100 000 IU Vitamin D2
Drug: Vitamin D2
100 000 IU vitamin D2, one time bolus dose
3: Placebo Comparator
Placebo
Drug: Placebo
Placebo, 1 time bolus dose

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424619

Contacts
Contact: Janet M Pritchard, BSc KIN 905-521-2100 ext 74161 pritchar@hhsc.ca
Contact: Madeline Nixon, BSc KIN 905-521-2100 ext 74004 nixonm@hhsc.ca

Locations
Canada, Ontario
Henderson General Hospital, 711 Concession Street Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Principal Investigator: Alexandra Papaioannou, M.D., M.Sc.            
Sponsors and Collaborators
Hamilton Health Sciences
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Alexandra Papaioannou, M.D., M.Sc. McMaster University
  More Information

No publications provided

Responsible Party: McMaster University ( Dr. Alexandra Papaioannou )
Study ID Numbers: 06-449, P1975
Study First Received: January 17, 2007
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00424619     History of Changes
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Vitamin D
Hip fracture
Optimal level
Deficiency
Functional muscle strength

Study placed in the following topic categories:
Ergocalciferol
Fractures, Bone
Wounds and Injuries
Ergocalciferols
Disorders of Environmental Origin
Bone Density Conservation Agents
Trace Elements
Hip Fractures
Femoral Fractures
Vitamin D
Vitamin D2
Vitamins
Leg Injuries
Micronutrients
Calciferol

Additional relevant MeSH terms:
Growth Substances
Fractures, Bone
Physiological Effects of Drugs
Wounds and Injuries
Ergocalciferols
Disorders of Environmental Origin
Bone Density Conservation Agents
Hip Injuries
Pharmacologic Actions
Hip Fractures
Femoral Fractures
Vitamin D
Vitamins
Leg Injuries
Micronutrients

ClinicalTrials.gov processed this record on September 02, 2009