Fall Prevention by Alfacalcidol and Training — SPALT  

Aged Clinical Trial

Official title: Effects of a Multi-modal 12-month-intervention With Alfacalcidol Plus Calcium, Patient Education and a Mobility Program on the Number of Fallers Among Patients With an Impaired Kidney Function Aged 65 and Older.

Status Withdrawn

Clinical Trial Summary

Objective of the study is to evaluate the effect of a multimodal therapy on the basis of current guidelines on fall prevention consisting of a 12-months intervention with Alfacalcidol and calcium, patient education and a mobility program in a group of patients 65 years of age or older with an impaired renal function in comparison to a group receiving usual care.

Clinical Trial Description

The risk of falling increases with age. An impaired renal function is an additional risk factor. Guidelines and systematic reviews suggest, that multimodal interventions are most likely to control this risk. This study evaluates, if patients at high risk for falls will benefit from a multimodal intervention simple and feasible enough to be transferred into general practice. Participants will be randomized either into an intervention group or a control group receiving usual care.

The multimodal intervention consists of:

• medication: Participants receive 1µg Alfacalcidol and 500mg Calcium daily

• mobility program: strength, balance and gait training twice a week for one hour

• patient education: a single meeting with teaching lessons on risk factors for falling and modes of fall prevention followed by an evaluation of the individual fall risk and corresponding recommendations to reduce it ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls
• Aged
• Chronic Renal Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic

• NCT number: NCT00483275
• Study type: Interventional
• Source: Ruhr University of Bochum
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2007
• Completion date: September 2009