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

NCT00168909 | Completed Phase 4 DMC

• 1 other identifier: ek.213-07 (IRB)
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Osteoporosis, Postmenopausal; Osteopenia; Falls

Keywords

osteoporosis; frailty; falls

Outcome Measures

Primary Outcomes (1)

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

  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

  3 years

Study Arms (2)

1

EXPERIMENTAL

alfacalcidol 1µg/d

Drug: alfacalcidol

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

alfacalcidol DRUG

alfacalcidol 1 µg once daily, oral, for 3 years

1

placebo DRUG

placebo once daily, oral, for 3 years

2

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

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

Berlin, 12200, Germany

Location

Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen

Stuttgart, 73732, Germany

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Osteoporosis; Frailty

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dieter Felsenberg, Prof. Dr.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: May 1, 2008
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

DE (2)