Fall Prevention by Alfacalcidol and Training

NCT ID: NCT00483275

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-09-30

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.

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

Conditions

Accidental Falls; Chronic Renal Insufficiency; Aged

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Alfacalcidol

Intervention Type: DRUG

Balance, gait and strength training

Intervention Type: BEHAVIORAL

Patient education

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: collaborator

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Principal Investigators

Prof. Dr. med. Ludger Pientka, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum

Herne, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

EudraCT 2006-006205-83

Identifier Type: -

Identifier Source: secondary_id

GER-001-SP

Identifier Type: -

Identifier Source: org_study_id