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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168909
• Other study ID #: ek.213-07 (IRB)
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: May 8, 2008
• Start date: June 2003
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: May 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falls
• Osteopenia
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• alfacalcidol
alfacalcidol 1 µg once daily, oral, for 3 years
• placebo
placebo once daily, oral, for 3 years

Locations

Country	Name	City	State
Germany	Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin	Berlin
Germany	Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)		3 years	Yes
Secondary	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	Yes