Fall Prevention by Alfacalcidol and Training

• Status: Withdrawn
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruhr University of Bochum
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Alfacalcidol; Hydroxycholecalciferols

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