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Completed

NCT Number: NCT00168909

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

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)

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Falls Frailty Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Alfacalcidol

Drug

alfacalcidol 1 µg once daily, oral, for 3 years

Placebo

Drug

placebo once daily, oral, for 3 years

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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