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| ID | Type | Description | Link |
|---|---|---|---|
| P1975 |
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| Name | Class |
|---|---|
| Merck Frosst Canada Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 50 000 IU Vitamin D2 |
|
| 2 | Active Comparator | 100 000 IU Vitamin D2 |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D2 | Drug | 50 000 IU vitamin D2, one time bolus dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Parathyroid Hormone (PTH) | Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline. | Baseline |
| Calcium | Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks. | Baseline, 4 weeks |
| Phosphate | Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline. | Baseline |
| Alkaline Phosphatase | Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline. | Baseline |
| Hemoglobin | Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Papaioannou, M.D., M.Sc. | McMaster University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21689448 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 50 000 IU Vitamin D2 | 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| FG001 | 100 000 IU Vitamin D2 | 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| FG002 | Placebo | Placebo at beginning of study and 1000IU vitamin D3 for 90 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 4 Week |
| |||||||||||||
| 3 Month |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 50 000 IU Vitamin D2 | 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| BG001 | 100 000 IU Vitamin D2 | 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants who completed the TUG test is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional TUG test at this time point. | Posted | Mean | Full Range | seconds | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 50 000 IU Vitamin D2 | 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fractured hip | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Papaioannou | McMaster University | 905-521-2100 | 77715 | papaioannou@hhsc.ca |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Vitamin D2 | Drug | 100 000 IU vitamin D2, one time bolus dose |
|
|
| Placebo | Drug | Placebo, 1 time bolus dose |
|
| Creatinine |
Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline. |
| Baseline |
| 3 months |
| 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Placebo | Placebo at beginning of study and 1000IU vitamin D3 for 90 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| OG001 | 100 000 IU Vitamin D2 | 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days |
| OG002 | Placebo | Placebo at beginning of study and 1000IU vitamin D3 for 90 days |
|
|
| 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 data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at <13 days were not included. 3-month data (n=47) was missing for 18 participants. | Posted | Mean | 95% Confidence Interval | nmol/L | Baseline, 4 weeks and 3 months |
|
|
|
| Primary | Parathyroid Hormone (PTH) | Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline. | Posted | Mean | Standard Deviation | pmol/L | Baseline |
|
|
|
| Primary | Calcium | Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks. | Posted | Mean | Standard Deviation | mmol/L | Baseline, 4 weeks |
|
|
|
| Primary | Phosphate | Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline. | Posted | Mean | Standard Deviation | mmol/L | Baseline |
|
|
|
| Primary | Alkaline Phosphatase | Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline. | Posted | Mean | Standard Deviation | U/L | Baseline |
|
|
|
| Primary | Hemoglobin | Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline. | Posted | Mean | Standard Deviation | g/L | Baseline |
|
|
|
| Primary | Creatinine | Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline. | Posted | Mean | Standard Deviation | µmol/L | Baseline |
|
|
|
| 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. | The number of participants who completed the 2WT is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional 2WT test at this time point. | Posted | Mean | Full Range | meters | 3 months |
|
|
|
| 1 |
| 22 |
| 2 |
| 22 |
| EG001 | 100 000 IU Vitamin D2 | 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days | 3 | 22 | 0 | 22 |
| EG002 | Placebo | Placebo at beginning of study and 1000IU vitamin D3 for 90 days | 1 | 20 | 2 | 20 |
| Pulmonary edmea and Myocardial infarction | Vascular disorders |
|
| gangrenous left foot requiring amputation | Surgical and medical procedures |
|
| Death | Respiratory, thoracic and mediastinal disorders |
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| Death | Cardiac disorders |
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| Renal failure | Renal and urinary disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Trip and fall | Musculoskeletal and connective tissue disorders |
|
| Abdominal Distention, nausea, vomiting | Gastrointestinal disorders |
|
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| D007869 |
| Leg Injuries |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| 4-week |
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| 3-month |
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|