Fall Prevention by Alfacalcidol and Training (SPALT)

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Aged; Chronic Renal Insufficiency; Accidental Falls
• Intervention / Treatment: Behavioral: Patient education; Drug: Alfacalcidol; Behavioral: Balance, gait and strength training

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 484
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Herne, NRW, Germany, 44627
      • Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of fallers	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of falls	One year
Number of fractures	One year
Performance in balance and mobility	One year
Fear of falling	One year
Rate of hypercalcaemia	One year

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Principal Investigator: Prof. Dr. med. Ludger Pientka, MD, MPH, Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: June 6, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (Estimate): June 7, 2007

Study Record Updates

• Last Update Posted (Estimate): July 21, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Exercise Training; Patient Education; Accidental Falls; Accident Prevention; Alfacalcidol
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Alfacalcidol; Hydroxycholecalciferols
• Other Study ID Numbers: GER-001-SP; EudraCT 2006-006205-83