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CompletedNCT00168909Updated May 9, 2008

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

A Phase 4 interventional study of alfacalcidol and placebo in Osteoporosis, Postmenopausal, Osteopenia and Falls, sponsored by Charite University, Berlin, Germany. Completed at 2 sites in Germany. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2008-05-09.

Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
65 Years and older
Sex
Female
01

Study 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)

02

Conditions studied

  • Osteoporosis, Postmenopausal
  • Osteopenia
  • Falls

Keywords

  • osteoporosis
  • frailty
  • falls
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 282 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • age > 65 years
  • postmenopausal women
  • osteopenia/osteoporosis as defined by WHO criteria

Exclusion 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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
282 participants (actual)

Study arms

  • Experimental
    1

    alfacalcidol 1µg/d

    Drug: alfacalcidol

  • Placebo comparator
    2

    placebo

    Drug: placebo

Interventions

  • Drugalfacalcidol

    alfacalcidol 1 µg once daily, oral, for 3 years

  • Drugplacebo

    placebo once daily, oral, for 3 years

06

What researchers measure

Primary outcomes

  1. primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)

    Time frame: 3 years

Secondary outcomes

  1. 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

07

Study locations

2 sites
  • Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
    Berlin, 12200, Germany
  • Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
    Stuttgart, 73732, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00168909
Lead sponsor
Charite University, Berlin, Germany
First posted
Sep 15, 2005
Start date
Jun 2003
Primary completion
Jul 2007
Completion
May 2008
Last update
May 9, 2008

Study contacts

Dieter Felsenberg, Prof. Dr.
study chair · Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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