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

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424619
• Other study ID #: 06-449
• Secondary ID: P1975
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2007
• Last updated: May 11, 2012
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: May 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Vitamin D2
50 000 IU vitamin D2, one time bolus dose
• Vitamin D2
100 000 IU vitamin D2, one time bolus dose
• Placebo
Placebo, 1 time bolus dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Merck Frosst Canada Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D3 (25-OHD)	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).	Baseline, 4 weeks and 3 months	No
Primary	Parathyroid Hormone (PTH)	Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.	Baseline	No
Primary	Calcium	Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.	Baseline, 4 weeks	No
Primary	Phosphate	Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.	Baseline	No
Primary	Alkaline Phosphatase	Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.	Baseline	No
Primary	Hemoglobin	Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.	Baseline	No
Primary	Creatinine	Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.	Baseline	No
Secondary	Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months	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.	3 months	No
Secondary	Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months	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.	3 months	No