Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study) - Full Text View

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00168909

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 IV

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Alfacalcidol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls

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

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

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

Keywords provided by Charite University, Berlin, Germany:

osteoporosis
frailty
falls

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
1-hydroxycholecalciferol
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Hydroxycholecalciferols

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009