Phase 4
Completed N=65
A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Source: ClinicalTrials.gov NCT00424619 ↗Enrolled (actual)
65
Serious AEs
7.8%
Results posted
Jun 2012
Primary outcomePrimary: 25-hydroxyvitamin D3 (25-OHD) — 53.5; 58.4; 46.7; 84.5 nmol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 25-hydroxyvitamin D3 (25-OHD) |
53.5; 58.4; 46.7; 84.5; 75.6; 69.3 | — |
| PRIMARY Parathyroid Hormone (PTH) |
5.35; 5.10; 4.2 | — |
| PRIMARY Calcium |
2.10; 2.12; 2.08; 2.26; 2.31; 2.28 | — |
| PRIMARY Phosphate |
0.86; 0.97; 0.94 | — |
| PRIMARY Alkaline Phosphatase |
98.6; 78.7; 79.4 | — |
| PRIMARY Hemoglobin |
102.2; 107.9; 108.6 | — |
| PRIMARY Creatinine |
70.5; 77.4; 73.7 | — |
| SECONDARY Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months |
26.2; 19.1; 18.1 | — |
| SECONDARY Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months |
60.2; 80.3; 63.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00424619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.