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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168909

Enrollment

282

Registered

2005-09-15

Start date

2003-06-30

Completion date

2008-05-31

Last updated

2008-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal, Osteopenia, Falls

Keywords

osteoporosis, frailty, falls

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)

Interventions

DRUGalfacalcidol

alfacalcidol 1 µg once daily, oral, for 3 years

DRUGplacebo

placebo once daily, oral, for 3 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026