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Does taking vitamin D supplements reduce fall- related fractures among geriatric patients? Mohamad Beydoun Kim Kirkpatrick Jeffrey Oboite Rafael Otero De Santiago

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Page 1: Group 8 Systematic Review Presenation

Does taking vitamin D supplements reduce fall-related fractures among geriatric

patients?

Mohamad BeydounKim KirkpatrickJeffrey Oboite

Rafael Otero De Santiago

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Patient caseMC is a 68 y/o caucasian female who lives at villages of Homeland apartments alone. She comes to the pharmacy to pick up her medications and asked the pharmacist a question regarding vitamin D supplements. A close friend of hers recently had a fall-related fracture and has her worried. She has heard that vitamin D can help lower your chances of falls and fractures and wants to know if vitamin D would be beneficial for her in the future.

Home Medications:● Escitalopram 10mg PO QD● Metoprolol Succinate 25mg PO QD● Simvastatin 10mg PO QD● Albuterol 1-2 puffs every 4-6 hrs PRN

PMH:● Depression● Hypertension● Hyperlipidemia● Asthma

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Vitamin D1

• Vitamin D is a fat-soluble vitamin• Function

• Promotes calcium absorption in the gut

• Maintains adequate serum calcium and phosphate concentrations

• Bone growth and bone remodeling

• With calcium - helps protect older adults from osteoporosis

• Vitamin D sources• UV B radiation (sun)• Fatty fish (salmon, tuna)• Cod liver oil• Beef liver• Cheese• Milk

Drug interactionsSteroids (prednisone)Weight loss drug (Orlistat)Cholesterol lowering drug

(cholestyramine)AEDs (phenytoin and phenobarbital)

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Vitamin D1,2

• Supplement Form

• D2 - ergocalciferol

• D3 - cholecalciferol

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Fall-related fractures3

• 1 out of 3 older people fall each year.

• 1 out of 5 falls causes serious injuries such as broken bone or head injury.

• Each year over 700,000 people are hospitalized because of fall related injuries like head injury or hip fractures

• Falling once makes people afraid of falling again so they would decrease their daily activities making their bones more fragile.

• Falling once double your chances of falling again.

Centers for Disease Control and Preventionhttp://www.cdc.gov/homeandrecreationalsafety/falls/adultfalls.html (Accessed 2016 April 5)

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Geriatric population4,5

• “Baby Boomers”• Define as people ≥ 65 y/o• Growing population• At high risk for falls because

of comorbidities or medications

• Fall-related fractures can be very complicate in this population

• Increase mortality rateEldercare Workforce Alliance http://www.eldercareworkforce.org/research/issue-briefs/research:america-solution-jobs-crisis-better-care-for-older-adults/ (Accessed 2016 April 5)

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Inclusion and Exclusion criteriaInclusion

• Clinical trials • Population ≥ 60 y/o• Fractures as an outcome• Vitamin D dietary

supplementation• Sample size ≥ 100• No year restriction

Exclusion• Secondary literature• Population < 59 y/o• Studies with bone mineral

density as the only outcome• Studies with falls as the only

outcome• Sample size < 99

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Search Strategy - PubMed

Filters: english language, human subjects, clinical trials, aged 65+ years

MeSH: “Vitamin D” + “Bone fractures” + “Accidental falls”

218 articles

22 articles

Applied our inclusion and exclusion criteria 5articles

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Search Strategy - Trip Database

Applied our inclusion and exclusion criteria

P: Geriatric, I: Vitamin D, C: (blank), O: Bone fracture

112 articles

2articles

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Search Strategy - Medline

English language

Vitamin D AND Geriatric AND Falls AND Fractures (TX All Text)

36 articles

22articles

Applied our inclusion and exclusion criteria/ Excluded duplicates

0articles

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POEM P Geriatric population

I Vitamin D dietary supplementation

C No vitamin D dietary supplementation or Placebo

O Incidence of fall-related fractures

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Article #1

Can Vitamin D Supplementation Reduce the Risk of Fracture in the Elderly? A Randomized Controlled Trial

Meyer et al. Can Vitamin D Supplementation Reduce the Risk of Fracture in the Elderly? A

Randomized Controlled Trial. Journal of Bone and mineral research. 2002. Vol 17, Num 4: 709-15.

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Meyer et al.6

P Patients >75 y/o with a life expectancy of more than half a year, able to take their medications and not permanently bedridden

I 400 IU of vitamin D3 daily

C Placebo

O Effectiveness of vitamin D in the prevention of fractures in the elderly people

T 2 years

S Doubled-blinded randomized controlled trial

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Results6

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Results6

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Limitations of the study6

• 761 patients discontinued the treatment after and average treatment period of 10 months.

• High percentage of females (75%)• High percentage of patients had a history of hip

fractures (30%).• The study was done in the city with the highest

incidence rates of hip fractures ever reported internationally.

• Both groups were receiving vitamin A and calcium.• No vitamin D adverse effects were reported• Possible reporting bias

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Clinical Implications6

• Vitamin D group, compared with the controlled group, did not show any significant benefit in the prevention of hip fractures and/or nonvertebral fractures.

• There was no difference in mortality between the control group and the vitamin D group

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Article #2

Vitamin D Supplementation and Fracture in Elderly Persons: A Randomized, Placebo-Controlled Clinical Trial

Lips et al. Vitamin D Supplementation and Fracture in Elderly Persons: A Randomized, Placebo-

Controlled Trial. Ann Intern Med. 1996. 124: 400-406.

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Lips et al.7

P Patients ≥ 70 y/o

I 4000 IU of vitamin D3 daily

C Placebo

O Hip and peripheral bone fractures

T 4 years

S Doubled-blinded randomized controlled trial

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Results7

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Results7

• Kaplan-Meier display of cumulative proportion of participants with first hip fracture

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Limitations of the study7

• Additional medications taken during the study were not reported

• Baseline chronic disease states were not reported• Frailer elderly persons refrained from participation

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• Subgroup analysis may reveal confounding variables• Vitamin D3 4000 IU daily does not reduce incidence of

bone fracture in Dutch elderly population

Clinical Implications7

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Article #3Annual High-Dose Oral Vitamin D and Falls and Fractures in Older Women A Randomized Controlled Trial

Sanders et al. Annual High-Dose Oral Vitamin D

and Falls and Fractures in Older WomenA Randomized Controlled Trial. JAMA. 2010;

303(18): 1815-22

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Sanders et al.8

P Women >70 y/o with a high risk of hip fracture

I 500,000 IU of vitamin D3 orally once a year

C Placebo

O Falls and fractures

T 4 years

S Double-blinded, placebo-controlled randomized trial

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Results8

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Results8

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Results8

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Limitations of the study8

• Possible reporting bias• Self-reported falls • Only radiologically confirmed fractures were

reported in the study • Baseline characteristics obtained through questionnaire • Patient population • Possible confounding

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Clinical Implications8

• Vitamin D resulted in higher incidence of falls and provided no benefit in reduction of fractures

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Article #4 Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in residential accommodation

Law et al. Vitamin D supplementation and the prevention of fractures and falls:

results of a randomised trial in elderly people in residential accommodation. Age

and ageing. 2006; 35: 482-486

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Law et al.9

P Patients > 60 y/o not currently taking vitamin D, calcium, or other drugs that can increase bone density.

I 1100 IU of vitamin D2 daily

C No vitamin D (no placebo)

O Nonvertebral fractures, hip fractures and falls

T 10 months

S Randomized controlled trial of cluster design

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Results9

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Limitations of the study9

• Possible selection bias since data on ineligible patients was not provided.

• 10 months long• No blinding• No placebo• Follow up was only 6 or 12 months

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Clinical Implications9

• There was no reduction in the incidence of fractures or falls in the vitamin D-treated group.

• Indeed, the incidence of fractures was directionally higher in the treated group (3.6%) than in the control group (2.6%), but this was not statistically significant.

• There was no evidence to support vitamin D supplementation and the prevention of fall-related fractures.

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Overview/Assessment

Articles Conclusions

Meyer et al.1 (2002) No benefit

Lips et al.2 (1996) No benefit

Sanders et al.3 (2010) Increased falls risk

Law et al.4 (2006) No benefit

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Limitations of our systematic review• Possible reporting bias

• No discontinuation of other medications or supplements• 80% of the participants in our studies were females• Dose of vitamin D were different

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RecommendationShould MC start vitamin D dietary supplementation for the prevention of fall-related fractures?

MC would not benefit from taking vitamin D supplements for the prevention of fall-related fractures

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References1. National Institutes of Health https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/#en1(Accessed 2016 April 5)2. GlobalRPh http://www.globalrph.com/2008/vitamin_d_synthesis.gif(Accessed 2016 April 5)3. Centers for Disease Control and Prevention http://www.cdc.gov/homeandrecreationalsafety/falls/adultfalls.html(Accessed 2016

April 5) 4. World Health Organization http://www.who.int/healthinfo/survey/ageingdefnolder/en/(Accessed 2016 April 5)5. Eldercare Workforce Alliance http://www.eldercareworkforce.org/research/issue-briefs/research:america-solution-jobs-crisis-

better-care-for-older-adults/(Accessed 2016 April 2016 5)6. Meyer et al. Can Vitamin D Supplementation Reduce the Risk of Fracture in the Elderly? A Randomized Controlled Trial. JJ

Bone Miner Res. 2002. Vol 17, Num 4: 709-15.7. Lips et al. Vitamin D Supplementation and Fracture in Elderly Persons: A Randomized, Placebo-Controlled Trial. Ann Intern

Med. 1996. 124: 400-4068. Sanders et al. Annual High-Dose Oral Vitamin D and Falls and Fractures in Older Women A Randomized Controlled Trial.

JAMA. 2010; 303(18): 1815-229. Law et al. Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in

residential accommodation. Age Ageing. 2006; 35: 482-486

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Questions