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Fall Prevention by Alfacalcidol and Training (SPALT)
This study has been withdrawn prior to enrollment.
(No final agreement with sponsor)
Sponsor:
Ruhr University of Bochum
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00483275
First received: June 6, 2007
Last updated: July 20, 2011
Last verified: July 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Accidental Falls Chronic Renal Insufficiency Aged | Drug: Alfacalcidol Behavioral: Balance, gait and strength training Behavioral: Patient education | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by Ruhr University of Bochum:
Primary Outcome Measures:
- Number of fallers [ Time Frame: One year ]
Secondary Outcome Measures:
- Number of falls [ Time Frame: One year ]
- Number of fractures [ Time Frame: One year ]
- Performance in balance and mobility [ Time Frame: One year ]
- Fear of falling [ Time Frame: One year ]
- Rate of hypercalcaemia [ Time Frame: One year ]
| Estimated Enrollment: | 484 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | September 2009 |
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| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00483275
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483275
Locations
| Germany | |
| Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum | |
| Herne, NRW, Germany, 44627 | |
Sponsors and Collaborators
Ruhr University of Bochum
Teva Pharmaceutical Industries
Investigators
| Principal Investigator: | Prof. Dr. med. Ludger Pientka, MD, MPH | Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum |
More Information
| ClinicalTrials.gov Identifier: | NCT00483275 History of Changes |
| Other Study ID Numbers: |
GER-001-SP EudraCT 2006-006205-83 |
| Study First Received: | June 6, 2007 |
| Last Updated: | July 20, 2011 |
Keywords provided by Ruhr University of Bochum:
|
Accidental Falls Accident Prevention Patient Education Exercise Training Alfacalcidol |
Additional relevant MeSH terms:
|
Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Alfacalcidol Hydroxycholecalciferols |
Bone Density Conservation Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on September 25, 2017