Hip FracturePhase 4NCT00424619
A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
A Phase 4 study testing Vitamin D2 in people with Hip Fracture, run by McMaster University.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Vitamin D2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fragility hip fracture patient
- Previous Vitamin D supplementation is okay.
Who cannot join
- 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
About this study
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.
Read the 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:
- 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.
- Conditions
- Hip Fracture
- Being tested
- Vitamin D2, Placebo
- Keywords
- Vitamin D, Hip fracture, Optimal level, Deficiency, Functional muscle strength
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Also called Ostoforte
50 000 IU vitamin D2, one time bolus dose
Vitamin D2Drug
Also called Ostoforte
100 000 IU vitamin D2, one time bolus dose
PlaceboDrug
Placebo, 1 time bolus dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 50 000 IU Vitamin D2 Receives: Drug: Vitamin D2 |
| 2 | Active comparator | 100 000 IU Vitamin D2 Receives: Drug: Vitamin D2 |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 4 weeks and 3 months
Parathyroid Hormone (PTH)
Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.
Measured: Baseline
Calcium
Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.
Measured: Baseline, 4 weeks
Phosphate
Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.
Measured: Baseline
Alkaline Phosphatase
Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.
Measured: Baseline
Hemoglobin
Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.
Measured: Baseline
Creatinine
Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Frosst Canada Ltd.
- Responsible party
- Principal investigator, Alexandra Papaioannou, McMaster University
- Investigators
- Alexandra Papaioannou, M.D., M.Sc., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424619
- Sponsor's protocol ID
- 06-449
- Other IDs
- P1975
- Status last verified
- May 2012
- First submitted
- 17 Jan 2007
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21689448
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT00424619
- Acronym / sponsor ID
- 06-449
- Conditions
- Hip Fracture
- Keywords
- Vitamin D, Hip fracture, Optimal level, Deficiency, Functional muscle strength
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Merck Frosst Canada Ltd.
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Jan 2007 (estimated)
- Results
- Posted 14 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Vitamin D250 000 IU Vitamin D2 |
| 2 | Active comparator | Drug: Vitamin D2100 000 IU Vitamin D2 |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fragility hip fracture patient
- Previous Vitamin D supplementation is okay.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2Also: Ostoforte50 000 IU vitamin D2, one time bolus dose | Drug | 1 |
| Vitamin D2Also: Ostoforte100 000 IU vitamin D2, one time bolus dose | Drug | 2 |
| PlaceboPlacebo, 1 time bolus dose | Drug | 3 |
Primary outcome
25-hydroxyvitamin D3 (25-OHD)
Time frame: Baseline, 4 weeks and 3 months
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
Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.
Calcium
Time frame: Baseline, 4 weeks
Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.
Phosphate
Time frame: Baseline
Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.
Alkaline Phosphatase
Time frame: Baseline
Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.
Hemoglobin
Time frame: Baseline
Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.
Creatinine
Time frame: Baseline
Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.
2 secondary outcomes
Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months
Time frame: 3 months
Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21689448Papaioannou 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Papaioannou, M.D., M.Sc. principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D2 in people with Hip Fracture, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-hydroxyvitamin D3 (25-OHD) (time frame: Baseline, 4 weeks and 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.