Study of the effect of supplementation of vitamin D deficiency in elderly people with hip fracture

Phase 1

• Conditions: Hip fracture and vitamin D deficiency; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-001778-40-ES
• Lead Sponsor: eonor Cuadra Llopart

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients aged > or =75 years with hip fracture by fragility and vitamin D deficiency.
Definitions:
* Fracture by fragility: understood as such those that are produced by trauma of low intensity (for example, falls from the own height in standing or smaller)
* Vitamin D deficiency: 25-OH-D3 serum levels <30 ng / mL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

* Presence of severe functional dependence prior to fracture of the femur (I. Barthel <35 points)
* Diagnosis of dementia to a moderate degree (defined on the Reisberg scale as GDS-FAST> 5).
* Medical conditions that contraindicate receiving vitamin D supplementation
- hypercalcemia (calcemia> 10.5 mg / dL),
- hyperparathyroidism
- chronic renal failure with GFR <30 mL / min,
- calcium lithiasis
- pathologies with risk of hypercalcemia (tuberculosis, sarcoidosis ...), as well as pathologies involving intestinal malabsorption.
- Hypersensitivity to the active substance or to any of the excipients.
* Use of drugs that interact with the use of vitamin D and with the risk of causing hypercalcemia (phenytoin, phenobarbital, primidone, digoxin).
* Reduced life expectancy (<12 months) due to the presence of advanced concomitant or end-of-life conditions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified