Fall Prevention by Alfacalcidol and Training (SPALT)

Ruhr University of Bochum

Status and phase

Withdrawn

Phase 4

Conditions

Accidental Falls

Aged

Chronic Renal Insufficiency

Treatments

Drug: Alfacalcidol

Behavioral: Balance, gait and strength training

Behavioral: Patient education

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00483275

EudraCT 2006-006205-83

GER-001-SP

Details and patient eligibility

About

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.

Full 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

Enrollment

484 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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