Clinical trial NCT01452243: Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial
Official title: Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fall
Fractures
Keywords: Vitamin D
Calcium
Elderly
Lead sponsor: Gerencia de Atención Primaria, Albacete
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2011-10-14
Enrollment: 704
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.

The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.

Detailed description: Background:

There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons. The objective of this study is to determine the effectiveness of calcium and vitamin D supplementation in improving musculoskeletal function and decreasing the number of falls in person aged over 65 years.

Design:

Phase III, randomized, double blind, placebo-controlled trial to evaluate the efficacy of already marketed drugs in a new indication. It will be performed at Primary Care doctor visits at several Healthcare Centers in different Spanish Health Areas. A total of 704 non-institutionalized subjects aged 65 years or older will be studied (sample size calculated for a statistical power of 80%, alpha error 0.05, annual incidence of falls 30% and expected reduction of 30% to 20% and expected loss to follow up of 20%). The test drug containing 800 IU of vitamin D and 1000 mg of calcium will be administered daily. The control group will receive a placebo. The subjects will be followed up over two years. The primary variable will be the incidence of spontaneous falls. The secondary variables will include: consequences of the falls (fractures, need for hospitalization), change in calcidiol plasma levels and other analytical determinations (transaminases, PTH, calcium/phosphorous, albumin, creatinine, etc.), change in bone mass by densitometry, change in muscle strength in the dominant hand and change in musculoskeletal strength, risk factors for falls, treatment compliance, adverse effects and socio-demographic data.

Eligibility criteria: Inclusion Criteria:

* Aged over 65 years with normal renal function
* Normal transaminase levels
* Normal calcium blood levels
* Not homebound (not immobilized) nor in socio-healthcare institutions.

Exclusion Criteria:

* Need for medical treatment with calcium or vitamin D
* Hypersensitivity to or contraindication for calcium or vitamin D
* Medical treatment that includes calcium or vitamin D
* Physical disability that impedes their collaboration
* Taking thiazide diuretics
* Oral anticoagulants
* Hormone replacement therapy
* Digitalis drugs
* Anticonvulsants or barbiturates
* Having any of the following diseases:

  * Lithiasis
  * Renal impairment (serum creatinine \>1.4 mg/dl)
  * Hypo or hyperthyroidism
  * Paget's disease
  * Chronic liver disease
  * Tumors
  * Sarcoidosis
  * Impaired intestinal absorption or chronic alcoholism (\>40 g/day).

Primary outcomes:
measure: Incidence of spontaneous falls.
timeFrame: 24 months.
Secondary outcomes:
measure: Consequence of falls.
timeFrame: 24 months.
measure: Change in calcidiol [25(OH)D3] plasma levels
timeFrame: 18 months.
measure: Change in bone mass (bone density or mineral content).
timeFrame: 24 months.
measure: Change in muscle strength in the dominant hand.
timeFrame: 24 months
measure: Changes in musculoskeletal function.
timeFrame: 24 months
measure: Serious adverse events or any other adverse event.
timeFrame: 24 months.
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Research Unit. Primary Care Head Office of Albacete
Study officials:
affiliation: Research Unit. Primary Care Head Office of Albacete
name: Jesús López-Torres, Hidalgo
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit. Primary Care Head Office of Albacete
name: Ignacio Párraga Martínez, Dr.
role: STUDY_CHAIR
affiliation: Research Unit. Primary Care Head Office of Albacete
name: Beatriz Navarro Bravo, Dr.
role: STUDY_CHAIR
affiliation: Research Unit. Primary Care Head Office of Albacete
name: Fernando Andrés Pretel, Dr.
role: STUDY_CHAIR
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