Clinical trial NCT00424619: A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Official title: A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fracture
Keywords: Vitamin D
Hip fracture
Optimal level
Deficiency
Functional muscle strength
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2007-01-19
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 25-hydroxyvitamin D3 (25-OHD)
timeFrame: Baseline, 4 weeks and 3 months
measure: Parathyroid Hormone (PTH)
timeFrame: Baseline
measure: Calcium
timeFrame: Baseline, 4 weeks
measure: Phosphate
timeFrame: Baseline
measure: Alkaline Phosphatase
timeFrame: Baseline
measure: Hemoglobin
timeFrame: Baseline
measure: Creatinine
timeFrame: Baseline
Secondary outcomes:
measure: Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months
timeFrame: 3 months
measure: Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1471-2474-12-135.