1. Hip Fracture & Vitamin D Update November 2007 Gregory Gahm, MD

2. Informational Tidbits
60-90% of NH residents fall annually
20-50% of LTC pts who fall DIE the following year
33% who have a hip fracture never walk again
From start (ambulance) to finish (therapy ends), the average direct cost of treating a hip fracture in Colorado is about $30,000 (Taxpayers pay most of it…)
Falls and hip fractures account for a significant percentage of malpractice suits and formal complaints against NHs
Evercare Colorado

3. Statistics Review RR = Relative Risk CI = Confidence Interval
RR is reported with a Confidence Interval statistically calculated based on magnitude of measured difference, # of study subjects, time…
RRs w/ CIs:
< 1.0: Result less likely to happen w/ Intervention
> 1.0: Result more likely to happen w/ Intervention
When CI includes 1.0: Can’t tell
If CI does not include 1.0, there is a 95% chance the same result would occur no matter how many times you repeat the study
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4. Falls and Fractures
Interventions shown to decrease falls in community-dwelling elderly:
Muscle strengthening / balance retraining [RR 0.80*; CI* ]
15 Week Tai Chi group exercise [RR 0.51; CI ] - only for active participants; benefits disappeared when exercise stopped
Withdrawal of psychotropic medication [RR 0.34; CI ]
Multidisciplinary, multifactorial, health/environment RF screening /intervention trials {No Rx changes} [RR 0.79; CI ]
Same interventions in LTCFs are markedly less effective
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5. Hip Fractures and PPIs Pts >50 yo on Proton Pump Inhibitors
(eg, Prilosec, Prevacid, Aciphex, Nexium, Omeprazole, Protonix)
13,556 hip fracture cases compared to 135,000 matched controls in the UK
RR of hip fracture increased with dose, duration and age
>1 year: RR = 1.44 [CI = ]
High Dose*: RR = 2.65 [CI = ]
*(>1.75x avg qd dose)
JAMA, Dec 27, 06; Vol 296:
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6. Clinical Trials of External Hip Protectors
Early studies with < 50% compliance:
Lauritzen (Lancet, 1993) 31 hip fxs in 418 controls [7.5%] vs 8 in 247 [3.2%] in treatment group.
NONE on a pad protected hip.
Kannus (NEJM, 2000) 21 hip fxs / 1000 pt-yrs [protected] vs 46 in the control group.
4 fxs on a pad protected hip.
Ekman (Lancet, 1997) 21 hip fxs during study period
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7. Clinical Trials of EHPs
Wiener & Birge (02): 19 fractures / 310 patient-years on unprotected hips - vs - 1 fracture / 320 patient-years on protected hips
Pooled data from 6 major trials:
3553 subjects
Hip fxs in 2.2% of those with EHPs vs 6.2% of control group
Average compliance rates estimated to be about 40%
NNT to prevent 1 fracture / year is  with 40% compliance or  with 85% compliance
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8. NH Chain National Hip Protector Study
14,000 patients in facilities were given the opportunity to wear hip protectors
chose NOT to wear them.
chose to wear hip protectors
Compliance was estimated to be 55-70%
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9. NH Chain National Hip Protector Study
At the end of 1 year / 3500 pt-years:
In those NOT wearing Hip Protectors…
 115 Fractures (= 33 Fractures per 1000 residents annually)
In the Hip Protector Intention to Treat group…
 45 Fractures (= 13 Fractures per 1000 residents annually)
Only 3 were in patients wearing EHPs
Comparing ‘Wearers’ to ‘NON-wearers’ –> 3 vs 42 Fxs
or 0.8 vs 12 Fractures / 1000 Patient-Years
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10. The HIP PRO RCT
Efficacy of a Hip Protector to Prevent Hip Fracture in NH Residents
1042 NH Residents, Mean age 85
Left or Right Pad Only
8 month avg participation
Compliance checked 3x/wk: 60-80% avg
Results: Same incidence of fractures on padded vs unpadded hips
JAMA; July 25, 2007; Vol 298:
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11. The Rebuttal
The JAMA article used a Hip Protector that has not been available since 2003!
The study pad and the one that replaced it were tested using a drop weight system in The study pad absorbed 30% of peak force, the replacement 75-90%
Most brands currently available still absorb only % of peak force, which may not be adequate to prevent a fracture
Human volunteer fallers using the new pad in 2004 did > 400 falls without pain or hip injury
Fall reflex characteristics (the baby / ice argument)
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12. So, are the major brands of EHPs available equivalent?
No. Brand makes a difference.
Some brands tested in RCTs have shown dramatic reductions in hip fractures (FallGard) or at least statistically significant decreases (HipSavers)
Some have shown NO difference or even MORE fractures (usu due to poor design, inadequate pad, or pad placement)
Many have never been studied in RCTs
Evercare Colorado

13. Evercare Colorado Hip Protector Study
3 Facilities chosen that historically [ ] had the highest number of hip fractures. There were 16 hip fractures among 200 patients in the previous 7 months
(Annually, 27.5 hip fractures would be expected to occur in this group, a number that was consistent from )
180 of these patients were identified as being at highest risk and given Hip Protectors (FallGard)
The 20 patients deemed to be at lowest risk for falls were excluded from the study
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14. Evercare Hip Protector Study
There were 3 hip fractures among these 180 pts the following year…
…none of them were wearing their hip protectors at the time of their fall / fracture
PS. There were also 3 fractures among the 20 persons excluded from the study…
Evercare Colorado

15. Implementation Issues
Lost Briefs
Mark them well / Inservice Staff
Acceptance by Facilities
Significant financial savings from keeping census up and patients alive
Fewer Complaint Surveys / Law suits
Improved MDS data (better surveys?)
No F Tags for ‘acceptable’ noncompliance rates
SIGNIFICANT findings studies all had only 35-60% compliance
Acceptance by Patients & Familes
Nonpharmacologic treatment that works
Families / patients appreciate the risk reduction in death, permanent disability, hospitalization / surgery, loss of Ambulation & Independent skills…
Noncompliance
Takes about 2-6 weeks for patients to get used to them
Routine Checks + immediate feedback to nursing & CNAs
Assistance from families – use information sheets
Evercare Colorado

16. Ordering FallGard Hip Protectors
631 Alexandria Dr
Naperville, IL 60565
Fax
Sizes: XS, S, M, L, XL, XXL, XXXL
Order the “Sewn-In Pad” version
Evercare Colorado

17. Vitamin D: The Basics
Essential for adequate intestinal absorption of Ca++
Vitamin D insufficiency:
Can compromise muscle strength & impair lower extremity function
Associated with Increased Arterial Calcification
Occurs in 75-85% of patients with Chronic Kidney Disease
(Prevalence of CKD in NHs is likely >60-75%)
Leads to Increased PTH -–> Higher Bone Turnover
Evercare Colorado

18. Vitamin D: The Problem
Most LTC residents have insufficient / deficient levels of Vitamin D
–> 70-98% in recently published studies
Evercare Colorado

19. Vitamin D and Falls Meta-analysis of RCTs in elderly (n=1237) -> 700 IU D2 = Avg Dose
Vitamin D reduced risk of falling by 22%
(OR 0.78; 95% CI ( ) compared to Ca++ or placebo
JAMA, April 28, 2004; Vol 291:
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20. Dosage of Vitamin D Needed to Reduce Falls
N=125 LTC residents
5 months of D2 supplements 200, 400, 600 or 800 IU qd
800 IU supplement was not enough to achieve “sufficient” Serum 25(OH) levels in 50% of those treated
Units / day 25 (OH) Vit D ng/ml RR falls
* ( )
JAGS 2007; 55:234
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21. Vitamin D2 vs D3
Most standard Ca++ combinations contain 200 IU of Vit D2
-> Available as 400 IU Caps & usu given 3 qd
-> D2 is only  2/3 as effective in raising Vit D levels as D3
-> 200 U Vitamin D2 =~ 140 U D3
-> Daily rec for Vit D2 would be 1500 IU qd
Vitamin D3 Caps of 50,000 & 5,000 units are available and can be given monthly (always with a meal)
-> Give with meals that contain fats or oils to stimulate bile acids & improve absorption
Evercare Colorado

22. Vitamin D3
Supplementation with IU qd of Vit D3 in seniors reduces both falls and fractures by 20-30%
Alternatively, give 50,000 IU q month of Vitamin D3
Lower doses have much less effect & do not correlate with decreased fracture rates with or without Ca++ supplementation
800 IU of Vitamin D3 qd undertreats 50% of pts
Current AMDA guideline: 1000 IU of Vitamin D3 qd
Evercare Colorado

23. Vitamin D: Resident Safety
Residents with Stage IV Kidney disease (GFR <15) may not benefit from getting Vitamin D3
History of Kidney Stones is generally not a contraindication, but history must be reviewed carefully
Recent studies show that doses of 100, ,000 IU / mo did not lead to adverse effects
No need to test Vit D-25(OH) routinely!
Lab test is MUCH more expensive (circa $50) than years of treatment
Prevalence is high enough to assume >4 of 5 elderly patients are deficient
Treating pts who aren’t deficient is very unlikely to cause harm & may have benefits
Malabsorption syndromes may require higher doses & measurement of 25 (OH) Vit D levels to find effective dose
Evercare Colorado

24. Vit D Deficiency & Prostate Cancer
14,916 men in Physicians' Health Study initially cancer-free
After 18 yrs of F/U, 1,066 subjects were identified with incident Prostate CA & compared their Vit D status with that of 1,618 cancer- free, age- and smoking-matched controls
Men with below-median levels of Vit D had a significantly higher risk of aggressive Prostate CA (OR 2.1)
Men with below-median levels of Vit D & the Vit D receptor polymorphism FokI ff had a higher risk of total and aggressive Prostate CA than those with above-median levels and the Ff or FF genotype (OR 1.9 & 2.5, respectively). 

Overall, 13-51% of the physicians in the study were Vit D deficient in the summer/fall & 36-77% were deficient in the winter/spring
Li H, Stampfer MJ, Hollis JBW, Mucci LA, Gaziano JM, et al. (2007) A Prospective Study of Plasma Vitamin D Metabolites, Vitamin D Receptor Polymorphisms, and Prostate Cancer. PLoS Med 4(3): e103 doi: /journal.pmed
Evercare Colorado

25. Link Between Serum Vit D & Heart Disease Risk
Levels of serum 25-OH D & CVD risk examined in 15,088 individuals age >20
7,186 men / 7,902 women
versampling of blacks, Hispanics & individuals aged > 60
Mean 25-OH D level = 30 ng/mL. Levels lower in women, older individuals, ethnic minorities, obese subjects & those with HTN or DM
OR of CVD comparing those w/ serum OH 25 D in lowest (<21) vs highest (>37) quartiles:
– HTN: – DM: – Obesity: 2.28 – High serum triglyceride: 1.47
Good safety at doses of IU per day
Vit D level < 21 assoc w/ immunological abnormalities, HTN & CHF
Author emphasized that 2000 IU/day is more likely to achieve adequate blood levels of Vit D for prevention of CVD & that there is compelling evidence that it reduces inflammation, lowers renin & angiotensin, may lower BP or blood vessel proliferation and may improve insulin sensitivity!
Norris, et al. Archives of Internal Medicine; June 11, 2007
Evercare Colorado

26. Calcium
Ca++ should still be given at doses of mg qd as multiple doses
–> never more than mg at a time because people can’t absorb more from a single dose
May give Ca++ with or without Vit D, as safety profile shows that the additional D2 will not cause harm (Norris study recommended 2000 IU / d or 60,000 IU q mo)
Evercare Colorado

27. Conclusions Falls are bad Hip Fractures are worse
We can have an immediate & long term impact with very little cost or effort
Every patient should be on the equivalent of ± IU of Vitamin D3 daily, given most easily as:
50,000 units monthly, or
10,000 units (2 x 5000 u caps) weekly
Every patient possible should be in GOOD Hip Protectors (eg, FallGard)
Continue Ca++ supplements at 500 mg bid - tid
Evercare Colorado

28. Obtaining Vitamin D3 Biotech-Pharmacal 50,000 IU capsule
OTC? I’m still researching this…
Biotech-Pharmacal
50,000 IU capsule
NDC # (Product ID 362A)
Bottles of 100 by prescription only for $15
5000 IU capsule
NDC # (Product ID A)
Bottles of 250 by prescription only for $7.85
Contact Brad Smith
Fax:
Cardinal will drop ship the item, but you'll have to speak with a representative and tell them you need to have it "drop shipped from “Biotech-Pharmacal"
Evercare Colorado

29. Vitamin D3 to reduce falls and Fractures References
Bischoff-Ferrari HA. Effect of vitamin D on falls: a meta-analysis. JAMA. 2004;291:
Bischoff-Ferrari HA. Fracture Prevention With Vitamin D,A Meta-analysis JAMA. 2005;293:
Sambrook PN, et al. Vitamin D deficiency is common in frail institutionalised older people in northern Sydney. Med J Aust 2002; 176:560
Le Boff MS. Occult vitamin D deficiency in postmenopausal US women with acute hip fracture. JAMA 1999; 281:1505–11.
Harwood RH, et al. A randomized, controlled comparison of different calcium & vitamin D supplementation regimens in elderly women after hip fracture: the Nottingham Neck of Femur Study (NoNOF). Age Ageing 2004; 33:45–51.
Semba RD. Vitamin D deficiency among older women with and without disability. Am J Clin Nutr 2000; 72:1529–34.
Flicker L. Serum vitamin D & falls in older women in residential care in Australia. J Am Geriatr Soc 2003; 51:1533–8.
Sahota O, Masud T, San P, Hosking DJ. Vitamin D insufficiency increases bone turnover markers and enhances bone loss at the hip in patients with established vertebral osteoporosis. Clin Endocrinol (Oxf ) 1999; 51:217–21.
Morris A, Nordin BEC. Relationship between serum hydroxyvitamin D and bone resorption markers in vitamin D insufficiency. Bone 2002; 31:626–30.
Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. Am J Clin Nutr 1999;69:842–56
Heaney R Symposium: Optimizing Vitamin D Intake for Populations with Special Needs: Barriers to Effective Food Fortification & Supplementation Barriers to Optimizing Vitamin D3 Intake for the Elderly; J. Nutr. 136: , April 2006
Bischoff-Ferrar HA. Higher 25-hydroxyvitamin D concentrations are associated with better lower-extremity function in both active and inactive persons aged 60 y. Am J Clin Nutr 2004;80:752–8.
NIH Web Site for Vitamin D recommendations :
Bio-Tech Pharmacal Web site
Evercare Colorado