Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483275
Status:
WITHDRAWN
Last Update Posted:
2011-07-21
First Post:
2007-06-06
Brief Title:
Fall Prevention by Alfacalcidol and Training
Sponsor:
Ruhr University of Bochum
Organization:
Ruhr University of Bochum
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No final agreement with sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPALT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2006-006205-83 | None | None | None |