Accidental FallsPhase 4SPALTNCT00483275
Fall Prevention by Alfacalcidol and Training
A Phase 4 study testing Alfacalcidol, Balance, gait and strength training and Patient education in people with Accidental Falls and Chronic Renal Insufficiency, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Chronic Renal Insufficiency, Aged
- What is being tested?
- Alfacalcidol, Balance, gait and strength training and Patient education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 484 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum
Herne, North Rhine-Westphalia, 44627
About this study
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.
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.
Read the 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
- Conditions
- Accidental Falls, Chronic Renal Insufficiency, Aged
- Being tested
- Alfacalcidol, Balance, gait and strength training, Patient education
- Keywords
- Accidental Falls, Accident Prevention, Patient Education, Exercise Training, Alfacalcidol
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfacalcidolDrug
Balance, gait and strength trainingBehavioural
Patient educationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fallers
Measured: One year
Secondary outcomes (5)
Number of falls
Measured: One year
Number of fractures
Measured: One year
Performance in balance and mobility
Measured: One year
Fear of falling
Measured: One year
Rate of hypercalcaemia
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startJun 2007
- Study completionSep 2009 (estimated)
Why it stopped: No final agreement with sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Investigators
- Prof. Dr. med. Ludger Pientka, MD, MPH, Principal investigator, Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483275
- Sponsor's protocol ID
- GER-001-SP
- Other IDs
- EudraCT 2006-006205-83
- Acronym
- SPALT
- Status last verified
- Jul 2011
- First submitted
- 6 Jun 2007
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00483275
- Acronym / sponsor ID
- SPALT / GER-001-SP
- Conditions
- Accidental Falls, Chronic Renal Insufficiency, Aged
- Keywords
- Accidental Falls, Accident Prevention, Patient Education, Exercise Training, Alfacalcidol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No final agreement with sponsor
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Jun 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfacalcidol | Drug | – |
| Balance, gait and strength training | Behavioural | – |
| Patient education | Behavioural | – |
Primary outcome
Number of fallers
Time frame: One year
5 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
Related trials for Accidental Falls
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Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
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Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. med. Ludger Pientka, MD, MPH principal investigator
Klinik für Altersmedizin und Frührehabilitation, Marienhospital Herne, Ruhr-Universität Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfacalcidol, Balance, gait and strength training and Patient education in people with Accidental Falls and Chronic Renal Insufficiency, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fallers (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.