Back to resultsInfluence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
Primary Purpose
Osteoporosis, Postmenopausal, Osteopenia, Falls
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
alfacalcidol
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring osteoporosis, frailty, falls
Eligibility Criteria
Inclusion Criteria: age > 65 years postmenopausal women osteopenia/osteoporosis as defined by WHO criteria Exclusion Criteria: Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year Chronic inflammatory rheumatoid disease Arthritis with continuous pain and influence on locomotion Inflammatory or metabolic bone disease, excluding osteoporosis. Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued 25-OH-Vitamin D3 < 12 ng/ml (12 ng/ml = 30 mmol/L) Systemic corticosteroid treatments of more than one month within previous 12 months Intolerability for alfacalcidol Hypercalcaemia (>2,7 mmol/l) Milk alkali syndrome Uncorrected, severe visual impairments Creatinin > 2.5 mg/dl (>220 µmol/L)
Sites / Locations
- Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
- Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
alfacalcidol 1µg/d
placebo
Outcomes
Primary Outcome Measures
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
Secondary Outcome Measures
secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies
Full Information
NCT ID
NCT00168909
First Posted
September 9, 2005
Last Updated
May 8, 2008
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00168909
Brief Title
Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
Official Title
Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.
primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal, Osteopenia, Falls
Keywords
osteoporosis, frailty, falls
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
alfacalcidol 1µg/d
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
alfacalcidol
Intervention Description
alfacalcidol 1 µg once daily, oral, for 3 years
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo once daily, oral, for 3 years
Primary Outcome Measure Information:
Title
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 65 years
postmenopausal women
osteopenia/osteoporosis as defined by WHO criteria
Exclusion Criteria:
Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
Chronic inflammatory rheumatoid disease
Arthritis with continuous pain and influence on locomotion
Inflammatory or metabolic bone disease, excluding osteoporosis.
Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
25-OH-Vitamin D3 < 12 ng/ml (12 ng/ml = 30 mmol/L)
Systemic corticosteroid treatments of more than one month within previous 12 months
Intolerability for alfacalcidol
Hypercalcaemia (>2,7 mmol/l)
Milk alkali syndrome
Uncorrected, severe visual impairments
Creatinin > 2.5 mg/dl (>220 µmol/L)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Felsenberg, Prof. Dr.
Organizational Affiliation
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
City
Stuttgart
ZIP/Postal Code
73732
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
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