Back to resultsFall Prevention by Alfacalcidol and Training (SPALT)
Primary Purpose
Accidental Falls, Chronic Renal Insufficiency, Aged
Status
Withdrawn
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Alfacalcidol
Balance, gait and strength training
Patient education
Sponsored by
About this trial
This is an interventional prevention trial for Accidental Falls focused on measuring Accidental Falls, Accident Prevention, Patient Education, Exercise Training, Alfacalcidol
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
Sites / Locations
- Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum
Outcomes
Primary Outcome Measures
Number of fallers
Secondary Outcome Measures
Number of falls
Number of fractures
Performance in balance and mobility
Fear of falling
Rate of hypercalcaemia
Full Information
NCT ID
NCT00483275
First Posted
June 6, 2007
Last Updated
July 20, 2011
Sponsor
Ruhr University of Bochum
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00483275
Brief Title
Fall Prevention by Alfacalcidol and Training
Acronym
SPALT
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
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
No final agreement with sponsor
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ruhr University of Bochum
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Chronic Renal Insufficiency, Aged
Keywords
Accidental Falls, Accident Prevention, Patient Education, Exercise Training, Alfacalcidol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfacalcidol
Intervention Type
Behavioral
Intervention Name(s)
Balance, gait and strength training
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Primary Outcome Measure Information:
Title
Number of fallers
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of falls
Time Frame
One year
Title
Number of fractures
Time Frame
One year
Title
Performance in balance and mobility
Time Frame
One year
Title
Fear of falling
Time Frame
One year
Title
Rate of hypercalcaemia
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. med. Ludger Pientka, MD, MPH
Organizational Affiliation
Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum
City
Herne
State/Province
NRW
ZIP/Postal Code
44627
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Fall Prevention by Alfacalcidol and Training
We'll reach out to this number within 24 hrs