Fall Prevention by Alfacalcidol and Training

Aged Clinical Trial

— SPALT  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00483275
• Other study ID #: GER-001-SP
• Secondary ID: EudraCT 2006-006
• Status: Withdrawn
• Phase: Phase 4
• First received: June 6, 2007
• Last updated: July 20, 2011
• Start date: June 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2011
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 484
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Men and women who are 65 years of age or older

• Personal history of at least one movement-related, non-syncopal fall, either within the past year OR earlier with additional findings of an increased fall risk during screening examination.

• Creatinine-clearance of 30 to 60 ml/min equivalent to a moderately impaired kidney function (stage 3) according to the classification of the Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF).

Exclusion Criteria:

• Immobility with inability to go out and participate in training course

• History of a fracture or of a stroke provided the event has occurred in the last 3 months

• Presence of a physical or mental disorder that has led to a set-up or to a planned set-up for a statutory care

• Severe dementia

• Severe disorder of speech or comprehension

• Disease that rules out participation during the intervention period or that would deteriorate as a result of type of intervention (e.g. absorptive hypercalciuria, nephrocalcinosis, calcium containing renal calculi or hypophosphataemia)

• Hypersensitivity (allergy) to Alfacalcidol, groundnuts, groundnut oil or Soya

• Vitamin-D hypersensitivity or -intoxication

• Simultaneous intake of vitamin D and its derivatives.

• Participation in any other clinical trial, that is still ongoing or has been completed less than 3 months prior date of intended inclusion

• Substitution of more than 500 mg calcium per day

• Planned medical therapy during the period of intervention that requires long-term suspension of intervention.

• Presence of hypercapnia of over 2.6mmol/l, calcium x phosphate product of over 3.7 (mmol/l)2 and alkalosis with venous blood-pH- reading of over 7.44 (milk-alkali-syndrome, Burnett syndrome)

• Hypercalcaemia (e.g. as a result of hyperparathyroidism, an overdose of vitamin D, paraneoplastic syndrome, osseous metastases, sarcoidosis, Boeck´s disease, osteoporosis induced by immobilisation) or hypermagnesemia according to normative values of the engaged laboratory

• Hereditary fructose intolerance

• Commitment into an institution

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

Intervention

Drug:
• Alfacalcidol

Behavioral:
• Balance, gait and strength training

• Patient education

Locations

Country	Name	City	State
Germany	Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum	Herne	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Teva Pharmaceutical Industries

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fallers		One year
Secondary	Number of falls		One year
Secondary	Number of fractures		One year
Secondary	Performance in balance and mobility		One year
Secondary	Fear of falling		One year
Secondary	Rate of hypercalcaemia		One year