Trial record 10 of 515 for:    (elderly OR senior) AND osteoporosis AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168909
First received: September 9, 2005
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Osteoporosis, Postmenopausal
Osteopenia
Falls
Drug: alfacalcidol
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168909

Locations
Germany
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, Germany, 12200
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Stuttgart, Germany, 73732
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Chair: Dieter Felsenberg, Prof. Dr. Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Dieter Felsenberg, Charité - Campus Benjamin Franklin, Centre for Muscle and Bone Research, Hindenburgdamm 30, 12200 Berlin, Germany
ClinicalTrials.gov Identifier: NCT00168909     History of Changes
Other Study ID Numbers: ek.213-07 (IRB)
Study First Received: September 9, 2005
Last Updated: May 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
osteoporosis
frailty
falls

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alfacalcidol
Hydroxycholecalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 26, 2014