Fall Prevention by Alfacalcidol and Training

Registration Number
NCT00483275
Lead Sponsor
Ruhr University of Bochum
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 c...

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 g...

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
484
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).
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Number of fallersOne year
Secondary Outcome Measures
NameTimeMethod
Number of fallsOne year
Number of fracturesOne year
Performance in balance and mobilityOne year
Fear of fallingOne year
Rate of hypercalcaemiaOne year

Trial Locations

Locations (1)

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

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Herne, NRW, Germany

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