prevention of falls and fractures in old people by administration of calcium and vitamin d. randomized clinical trial

Conditions: Fall; Fractures

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.

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).

Keywords: vitamin d calcium elderly