Fall Prevention by Alfacalcidol and Training (SPALT)

This study has been withdrawn prior to enrollment.
(No final agreement with sponsor)
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
Accidental Falls
Accident Prevention
Patient Education
Exercise Training
Alfacalcidol

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hydroxycholecalciferols
1-hydroxycholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 24, 2014