Clinical trial NCT00483275: Fall Prevention by Alfacalcidol and Training
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Accidental Falls
Chronic Renal Insufficiency
Aged
Keywords: Accidental Falls
Accident Prevention
Patient Education
Exercise Training
Alfacalcidol
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2007-06-07
Enrollment: 484
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Number of fallers
timeFrame: One year
Secondary outcomes:
measure: Number of falls
timeFrame: One year
measure: Number of fractures
timeFrame: One year
measure: Performance in balance and mobility
timeFrame: One year
measure: Fear of falling
timeFrame: One year
measure: Rate of hypercalcaemia
timeFrame: One year
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum
state: NRW
Study officials:
affiliation: Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum
name: Prof. Dr. med. Ludger Pientka, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: