Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT00168909

Collaborator

(none)

282

Enrollment

Locations

Arms

Duration (Months)

141

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal Osteopenia Falls	Drug: alfacalcidol Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

282 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 alfacalcidol 1µg/d	Drug: alfacalcidol alfacalcidol 1 µg once daily, oral, for 3 years
Placebo Comparator: 2 placebo	Drug: placebo placebo once daily, oral, for 3 years

Arm

Intervention/Treatment

Experimental: 1

alfacalcidol 1µg/d

Drug: alfacalcidol

alfacalcidol 1 µg once daily, oral, for 3 years

Placebo Comparator: 2

placebo

Drug: placebo

placebo once daily, oral, for 3 years

Outcome Measures

Primary Outcome Measures

primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls) [3 years]

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 [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin	Berlin		Germany	12200
2	Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen	Stuttgart		Germany	73732