Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial

Phase 3

• Conditions: Fall; Fractures
• Interventions: Drug: Vitamin D and calcium suplementation

• Registration Number: NCT01452243
• Lead Sponsor: Gerencia de Atención Primaria, Albacete

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.

Study Timeline

• Study Start: 2008-11
• Status Verified: 2011-10
• Study First Submitted: 2011-10-09
• Study First Submitted QC: 2011-10-11
• Last Update Submitted: 2011-10-11
• Study First Posted: 2011-10-14
• Last Update Posted: 2011-10-14
• Primary Completion: 2011-11
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 704

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium and vitamin D	Vitamin D and calcium suplementation	The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.

Primary Outcome Measures

Name	Time	Method
Incidence of spontaneous falls.	24 months.	The primary variable will be the incidence of spontaneous falls according to the FICSIT (Frailty and Injury: Cooperative Study of Intervention Techniques) definition: "Unintentionally coming to rest on the ground, floor, or other lower level. Coming to rest against furniture or a wall was not counted as a fall".

Secondary Outcome Measures

Name	Time	Method
Consequence of falls.	24 months.	Bone fractures at any location, need for healthcare, need for hospitalization, bed-ridden.
Change in calcidiol [25(OH)D3] plasma levels	18 months.	Determined by RIA (Vitamin D deficiency is defined as a calcidiol plasma level lower than 10ng/ml).
Change in bone mass (bone density or mineral content).	24 months.	By densitometry (risk of fracture). Osteoporosis will be diagnosed based on a densitometry T-score of less than 2.5 in the vertebral column, according to WHO criteria.
Change in muscle strength in the dominant hand.	24 months	Determined by dyanometry (with a mean of 3 attempts to obtain a muscle strength measurement).
Changes in musculoskeletal function.	24 months	By the timed up and go test (the elderly person gets up from a chair with arms, walks three meters, turns round, walks back and sits down again). Taking more than 20 seconds indicates a high risk for falls.
Serious adverse events or any other adverse event.	24 months.	An adverse event is considered as any untoward medical occurrence in any patient included in the study which does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.

Trial Locations

Locations (1)

Research Unit. Primary Care Head Office of Albacete; 🇪🇸 Albacete, Spain