Fall Prevention by Alfacalcidol and Training (SPALT)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Accidental Falls; Chronic Renal Insufficiency; Aged	Drug: Alfacalcidol; Behavioral: Balance, gait and strength training; Behavioral: Patient education	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	484 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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.
Study Start Date :	June 2007
Estimated Study Completion Date :	September 2009

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Number of fallers [ Time Frame: One year ]

Secondary Outcome Measures :

1. Number of falls [ Time Frame: One year ]
2. Number of fractures [ Time Frame: One year ]
3. Performance in balance and mobility [ Time Frame: One year ]
4. Fear of falling [ Time Frame: One year ]
5. Rate of hypercalcaemia [ Time Frame: One year ]

Eligibility Criteria

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Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Ruhr University of Bochum

Teva Pharmaceutical Industries

Investigators

Principal Investigator:	Prof. Dr. med. Ludger Pientka, MD, MPH	Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00483275 History of Changes
Other Study ID Numbers:	GER-001-SP; EudraCT 2006-006205-83
First Posted:	June 7, 2007
Last Update Posted:	July 21, 2011
Last Verified:	July 2011

Keywords provided by Ruhr University of Bochum:

Accidental Falls; Accident Prevention; Patient Education; Exercise Training; Alfacalcidol

Additional relevant MeSH terms:

Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Alfacalcidol; Hydroxycholecalciferols	Bone Density Conservation Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Growth Substances