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ANVITAD: Calcium and Vitamin D for Fall and Fracture Prevention in the Elderly
NCT01452243Phase 3
Key facts
- Status
- Unknown
- Start
- Nov 2008
- Primary completion
- Nov 2011
- Countries
- 1
- Sponsor
- Gerencia de Atención Primaria de Albacete
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Conditions
- fallsbone fracture
01
Overview
Phase 3, randomised, double-blind trial in falls and bone fracture comparing Calcium and vitamin D with Placebo (2 arms). Primary endpoint: Incidence of spontaneous falls at 24 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Calcium and vitamin D
Daily administration of chewable tablets containing 800 IU of vitamin D and 1200 mg of calcium.
Placebo
Daily administration of placebo.
03
Who it enrols
Non-institutionalized adults over 65 with normal renal, hepatic, and calcium levels, excluding those on interacting medications or with diseases affecting bone metabolism.
04
Endpoints
Primary
Incidence of spontaneous falls
Secondary
Consequence of falls (fractures, need for hospitalization)
Change in calcidiol [25(OH)D3] plasma levels
Change in bone mass (bone density or mineral content)
Change in muscle strength in the dominant hand
Changes in musculoskeletal function
Serious adverse events or any other adverse event
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