Achy Breaky Bones Hilary Rowe, BScPharm VIHA Pharmacy Resident 2009-10 Geriatrics Rotation Sept 30,...
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Transcript of Achy Breaky Bones Hilary Rowe, BScPharm VIHA Pharmacy Resident 2009-10 Geriatrics Rotation Sept 30,...
Achy Breaky Bones
Hilary Rowe, BScPharm
VIHA Pharmacy Resident 2009-10
Geriatrics Rotation
Sept 30, 2009
Outline
• Objectives• Introduction to the Patient• Review of Systems• DRP’s• Osteoporosis• Evidence• Recommendation• Monitoring
Objectives
• Review pathophysiology & diagnostic criteria for osteoporosis
• Review Evidence of teriparatide & zoledronic acid
• Discuss therapeutic options for a 94 yo osteoporotic female
• Discuss decision & monitoring
Mrs. FT
• ID: 94 yo female• Admitted:
– urinary retention from a UTI (resolved)
• Allergies: – Sulpha (reaction unknown)
• SH:– Lives alone, medications in vials, Pharmanet
regular, no Hx smoking, alcohol 2 oz drink before dinner
Mrs. FT
• Discharge Plan: – Return home to independent living
• PMHx: – Oophorectomy, hysterectomy, fractures, HTN,
GERD • Meds PTA:
– Felodipine, Cilazapril, Rabeprazole, Calcitonin, Tramadol/Acetaminophen, Alendronate, Acetaminophen, Calcium, Vitamin D
Review of Systems
System Findings Medications
CNS •MMSE 25/28•Dizzy if moves to quickly•Sleeping pill effective but wants to discontinue
Taper Zopiclone 3.75mg prn
Psych •Complains of low mood Started Mirtazapine 7.5 mg
EENT •Bilateral Cataract Surgery•Hearing Aids
Review of Systems
System Findings Medications
Cardio •Hypertension x 10 years
BP Sept 20-22nd : 120/78, 110/75, 138/85 mm Hg•Mitral Incompetence
Felodipine 2.5mg daily
Cilazapril 5mg daily
GI/Liver •GERD•Bowel movements q 3 days
Lansoprazole 30mg daily
Fruitlax daily
Review of Systems
System Findings Medications
MSK •Fracture right hip healing (March 09)•Hx fracture right wrist•Compression fractures of the spine: recent Sept 18th bone scan T12 & T3, old T8, T9, T10, T11, T12, L1, L4
Calcium carbonate 500mg elemental BID
Vit D 1000 Units daily
Alendronate 70mg Q Thursday (Started Oct 08)
Calcitonin nasal spray (Started Aug 12, 09)
Review of Systems
System Findings Medications
Pain •Upon ER admission-pain when transferring at home currently using pain scale to assess efficacy of Tramdol/ Acetaminophen and pain with physio
Tramadol/ Acetaminophen QID (Started Aug 12)
Calcitonin nasal spray (Started Aug 12)
Hydromorphone 0.5mg q 2h prn
Renal/ GU
•Retention from UTI (resolved)
Review of SystemsSystem Findings Medications
Heme •Sept 18th RBC 3.37 (↓), Hgb 118 (↓), Hct 0.34 (↓), MCV 101 (↑), RCDW 14.7 (↑)
Fluids/ Lytes
•K+ Sept 22nd & 28th 4.1 mmol/L•SIADH
-Urine Osmolality Sept 22nd 582 mmol/kg, 23rd 417mmol/kg
-Urine Na 114mmol/L Sept 22nd
-Na 130 mmol/L (↓) Sept 18th Na 134mmol/L (↓) Sept 28th
K+ 600mg SR BID
Salt on food, no fluid restriction yet
DRP’s
• Mrs. T requires continued assessment of pain on transfer and with physio despite present therapy of tramadol/Acetaminophen, calcitonin, and prn hydromorphone
• Mrs. T is at risk of unsteadiness and falls secondary to low Na and would benefit from monitoring and continued re-assessment of her fluid and salt intake
DRP’s
• Mrs. T is at risk of falls secondary to experiencing a drug-drug interaction with mirtazapine and alcohol causing drowsiness and a hangover effect and would benefit from counseling in regards to alcohol intake
• Mrs. T continues to experience multiple painful fractures despite standard therapy of Alendronate, Ca and Vit D and may benefit from consideration of additional therapies.
Osteoporosis
• Osteoclasts - ion channels that pump protons into extracellular space, ↓ in pH dissolves bone
• Osteoblasts deposit new bone
• Balance between these cells determines if bone is made, maintained, or lost
Osteoporosis
• Low bone mass and fragility due to:– peak bone mass is low– bone resorption is excessive
• trabecular bone loss and increased porosity in compact bone
– bone formation during remodeling is decreased
• Diagnosed by fragility fracture or T score <-2.5
Mrs. FT
• Patient is on Calcium, Vit D, Calcitonin, Alendronate
• Fracture right hip healing (March 09)• Compression Fractures of the spine: recent
Sept 18th bone scan T12 & T3• Lives alone• Cognitively intact and no compliance issues
Goals of Therapy
• Reduce hip and vertebral fractures • Prevent hospitalizations• Control Pain• Reduce side effects• Keep patient living independently (quality of
life)• Limit financial burden
Therapeutic Options
• Alendronate 70mg weekly
• Zoledronic acid 5mg infusion yearly
• Teriparatide 20 mcg subcutaneous injection daily
Studies to Discuss
• Alendronate vs Teriparatide– Alendronate: Decreases the rate of bone
resorption by blocking osteoclasts
• Zoledronic acid vs Placebo– Zoledronic Acid: Inhibits osteoclast resorption,
reducing bone turnover
• Teriparatide vs Placebo– Forteo: acts on osteoblasts to stimulate new bone
growth and improve bone density
Body et al. J Clin Endocrinol Metab 2002
P •Women 5 years post menopause 30-85 yo
I •Teriparatide 40mcg inj daily + po placebo
C •Placebo inj + Alendronate 10mg daily
O Results: 1º-Lumbar Spine (LS) DXA
Alendronate ↑6.6% (P<0.001), Teriparatide ↑ 15.1% (P<0.001)
2º-New Non vertebral fracture NNT 10 (P 0.042)
–AE:Mild hypercalcemia, leg cramps
S •Multicenter trial x 24 mo (ended at 14 mo)
Black et al. New Engl J Med 2007
P •Post menopause women 65-89 yo, •Previous bisphosphonate use = 2 yr wash out•Stratum 1-no Rx at time of randomization •Stratum 2-allowed Rx (raloxifene, calcitonin, medroxyprogesterone etc.)
I •Zoledronic acid 5mg IV infusion over 15 min
C •Placebo IV infusion over 15 min
Black et al. New Engl J Med 2007
O Results:
1º- New vertebral fracture (Stratum1) NNT 18
- New Hip Fracture NNT 107
2º- Any non vertebral fracture NNT 40
- Any clinical fracture NNT 26
- Clinical vertebral fracture NNT 60
- >2 vertebral fractures (Stratum 1) NNT 66
-↑ in BMD of total hip 6.02%, LS 6.71%, femoral neck 5.06% (P<0.001)
S •Multicenter trial x 24 mo (ended at 14 mo)
Neer et al. New Engl J Med 2001
P •Women previous vertebral fractures, ambulatory, 5+ years post menopause, average age was 69 years old
I •Teriparatide 20mcg subcutaneous daily
C •Placebo subcutaneous daily
O •Decrease in hip and vertebral fractures
S •Multicenter placebo controlled trial, over 24 months (average follow up 21 months)
Neer et al. New Engl J Med 2001
Outcome RR RRR ARR NNT/NNH
>1 New Vertebral Fracture
0.35 0.65 0.09 10.7
>1 New Fragility Fracture
0.47 0.53 0.03 34
Dizziness 0.03 0.7 0.03 34
Leg cramps 0.03 0.7 0.02 50
↑ BMD LS 9%, 3% femoral neck, total BMD 2%**Maximum exposure: Not >18 months, showed osteosarcomas in rats
Patient Considerations
• Cost $15,000 per 18 months
• Need to apply to Forteo Customer Care• Can patient do injections?• Can patient remember daily regimen?• Benefit to patient?• Drug interactions?
Recommendation
• Teriparatide 20mcg subcutaneous daily for 18 mo
• Have Forteo nurse teach patient in hospital• Calcium carbonate 500mg elemental BID• Vitamin D 2000 units daily• Continue to mobilize with walker
Monitoring
Adverse Effects
Monitor When Who
Dizzy/Lightheaded After daily inj Patient & Nurse
Leg cramps After daily inj Patient & Nurse
Serum Calcium Baseline, q6mo Physician
Urine Calcium Baseline, q6mo Physician
Uric Acid Baseline, q6mo Physician
Renal Function Baseline, q6mo Physician
Monitoring
Efficacy
Monitor When Who
New Fractures Ongoing Patient/Physician
Vit D & Calcium intake
At refills Pharmacist
Compliance- patient injecting daily & rotating sites
At refills Pharmacist
References
• Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. New Engl J Med 2001;344:1434-41.
• Black et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. New Engl J Med 2007;356:1809-22.
• Body JJ, Gaich GA, Scheele WH et al. A randomized double-blind trial to compare the efficacy of teriparatide [Recombinant Human Parathyroid Hormone (1–34)] with alendronate in postmenopausal women with osteoporosis. The Journal of Clinical Endocrinology and Metabolism 2002; 87(10):4528–4535.