SPALT: Fall Prevention by Alfacalcidol and Training

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00483275

Collaborator

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

484

Enrollment

Location

Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2007

Anticipated Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

Number of fallers [One year]

Secondary Outcome Measures

Number of falls [One year]
Number of fractures [One year]
Performance in balance and mobility [One year]
Fear of falling [One year]
Rate of hypercalcaemia [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum	Herne	NRW	Germany	44627

Sponsors and Collaborators

Ruhr University of Bochum
Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

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