Fall Prevention by Alfacalcidol and Training

NCT00483275 | Withdrawn Phase 4

• 2 other identifiers: GER-001-SPEudraCT 2006-006205-83
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Falls; Chronic Renal Insufficiency; Aged

Keywords

Accidental Falls; Accident Prevention; Patient Education; Exercise Training; Alfacalcidol

Outcome Measures

Primary Outcomes (1)

• Number of fallers

  One year

Secondary Outcomes (5)

• 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

Interventions

Alfacalcidol DRUG

Balance, gait and strength training BEHAVIORAL

Patient education BEHAVIORAL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum

Herne, North Rhine-Westphalia, 44627, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

alfacalcidol; Gait; Resistance Training; Patient Education as Topic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Prof. Dr. med. Ludger Pientka, MD, MPH

  Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: June 1, 2007
• Study Completion: September 1, 2009
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

DE (1)