1. Osteoporosis Update E. Michael Lewiecki, MD
Director, New Mexico Clinical Research & Osteoporosis Center
Director, Bone Health TeleECHO
University of New Mexico Health Sciences Center
Albuquerque, NM

2. Disclosure Institutional Grant / Research Support Consulting Speaking
Amgen
Consulting
Amgen, Radius
Speaking
Radius

3. Objectives Assess fracture risk in geriatric patients
Evaluate patients at risk for fracture
Explain current osteoporosis treatment guidelines

4. A Brief History of Osteoporosis How did we get where we are today?
E. Michael Lewiecki, MD
Personal Opinion

5. Osteoporosis Care CRISIS Better Worse Then Now
USA DXA Reimbursement Cuts (2007)
WHI (2002)
ONJ
AFF
Bureaucracy
Media Reports
FRAX
Limited Time
Fear of Side Effects
Guidelines
Competing Priorities
More Marketing
Drug Holidays
Approval of More Drugs
Calcium
Competing Guidelines
US Surgeon General’s Report
Vitamin D
Increasing Availability of DXA
Risk Communication
Bone Mass Measurement Act
Treatment Gap
Mass Marketing
CRISIS
Approval of Alendronate
WHO Diagnostic Criteria
DXA Introduced (1987)

6. US Hip Fracture Trends 2002-2015
Hip Fracture Rates
DXA Medicare Payments
$139
Osteoporosis Diagnosis
$82
$42
DXA Testing

7. Will I end up like my mother? Fracture Risk Assessment
Intervention Thresholds
Treatment
Follow-up

8. Indications for BMD Testing
Women age ≥ 65 and men age ≥ 70
Younger postmenopausal women, perimenopausal women, and men age based on risk factor profile
Adults with fragility fracture, disease or condition associated with low BMD or bone loss
Extracted from NOF Clinician’s Guide to Prevention and Treatment of Osteoporosis and ISCD Official Positions, 2015.

9. Open access (free download) at www.iscd.org
DXA Quality Matters
Open access (free download) at
DXA Best Practices. Lewiecki EM et al. J Clin Densitom. 2016;19(2):

10. WHO Classification of BMD
T-score
Normal
-1.0 or higher
Osteopenia
Between -1.0 and -2.5
Osteoporosis
-2.5 or lower
Severe Osteoporosis
-2.5 or lower + fragility fracture
Applies to postmenopausal women and men age 50 and older Cannot be used in premenopausal women and men under age 50. Should never be used in children (under age 20).
WHO Study Group ISCD Official Positions.

11. Caveats with WHO Classification
T-score ≤ -2.5 is not always osteoporosis
Example: could be osteomalacia or CKD-MBD
T-score > -2.5 may be osteoporosis
Example: fragility fracture, FRAX
Fracture risk is determined by more than BMD
Example: age, previous fracture, falls

12. Most Women with Hip Fracture have T-score > -2.5
Wainwright SA et al. J Clin Endocrinol Metab. 2005;90:

13. Look for Vertebral Fractures
VFs are common
Most VFs are not diagnosed
VFs have serious consequences
VFs predict future fractures
Detection of VFs may change diagnostic classification, assessment of fracture risk, and clinical management*
*NOF Guide: VF is indication for treatment regardless of BMD

14. Indications for Vertebral Imaging
Women age ≥ 70 and men age ≥ 80 if T-score is ≤ −1.0 at the LS, TH, or FN
Women age 65 to 69 and men age 70 to 79 if T- score is ≤ −1.5 at LS, TH, or FN
Postmenopausal women and men ≥ age 50 with specific risk factors:
Low-trauma fracture during adulthood (age ≥ 50)
Historical height loss ≥ 1.5 in.
Prospective height loss ≥ 0.8 in.
Recent or ongoing long-term glucocorticoid treatment
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis

15. VFA = Vertebral Fracture Assessment
A non-invasive method of diagnosing vertebral fractures by DXA with greater patient convenience, less cost, and lower radiation exposure than conventional X-ray

16. 3 Ways to Diagnose Osteoporosis
BMD testing (WHO, ISCD)
T-score ≤ -2.5 at LS, TH, FN, or 33%R
Fragility fracture (NBHA)
Low trauma hip fracture regardless of BMD
Low trauma vertebral, proximal humerus, pelvis or some distal forearm fractures with T-score between -1.0 and -2.5
FRAX (NBHA, USA only)
MOF risk ≥ 20% or HF risk ≥ 3%
WHO Technical Report. 1994; ISCD Official Positions
Siris ES et al. Osteoporos Int. 2014;25:

17. NOF Treatment Guidelines
Initiate pharmacologic treatment in postmenopausal women and men age ≥ 50 when . . .
T-score ≤ -2.5 or less at FN, TH, or LS, or . . .
Hip or vertebral (clinical or morphometric) fracture, . . .
T-score between -1.0 and -2.5 at FN, TH, or LS, and FRAX 10-year probability of hip fracture ≥ 3% or major osteoporotic fracture ≥ 20%
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis

18. Laboratory Evaluation
CBC
Blood chemistries
Creatinine
Calcium
Phosphorus
Albumin
Alkaline phosphatase
Liver enzymes
24-hour urine for calcium, sodium, and creatinine
25-OH-vitamin D
TSH
Bone turnover markers
FSH
Urinalysis
SIFE/SPE/UPE
Intact PTH
Dexamethasone suppression or urinary free cortisol
Bone biopsy?
Low phosphorous suggests osteomalacia.

19. Universal Recommendations
Regular weight-bearing exercise
Fall prevention
Avoid tobacco use and excess alcohol
Identification and treatment of risk factors for fracture
Calcium mg/day, ideally from diet
Vitamin D IU/day, target ≥ 30 ng/mL
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis

20. Medications for Osteoporosis
Inhibit Bone Resorption
Stimulate Bone Formation
Alendronate (Fosamax, generic)
Teriparatide (Forteo)
Risedronate (Actonel, Atelvia, generic)
Abaloparatide (Tymlos)
Ibandronate (Boniva, generic)
Zoledronate (Reclast, generic)
Denosumab (Prolia)
Raloxifene (Evista, generic)
Calcitonin (Miacalcin, Fortical)
Estrogen (various)
CE/BZA (Duavee)
Investigational compound: romosozumab (Evenity)

21. Individualizing Initial Treatment
Agent
Comments
Oral BPs
Pro: inexpensive, work well in many patients
Con: GI distress, avoid with low GFR, bad rep in lay press
ZOL
Pro: very long dosing interval, post-hip fracture data
Con: acute phase reaction, avoid with low GFR, IV
Dmab
Pro: long dosing interval, greatest BMD increase, SC
Con: FDA list of “side effects” (back pain, high cholesterol, etc.)
TPT
Pro: anabolic
Con: high cost, daily injection, refrigeration, rat osteosarcoma
Abalo
Pro: anabolic, no refrigeration, less hypercalcemia than TPT
Con: cost, daily injection, rat osteosarcoma
RLX
Pro: not a BP, decreases breast cancer risk
Con: VTE, hot flashes, no proven hip fracture decrease
Personal opinion.

22. Special Issues: Efficacy
Imminent fracture risk - a recent fracture imparts greater fracture risk than a remote fracture
Agents with proven hip fracture risk reduction: ALN, RIS, ZOL, Dmab (not IBN, salmon calcitonin)
Very high fracture risk - consider anabolic therapy (TPT, Abalo; Romo in FDA review)
Convenience of dosing (nursing home, polypharmacy) - injectable therapy (ZOL, Dmab)
Adherence to therapy - long acting agents may be preferable
Personal opinion.

23. Special Issues: Safety
Renal function – Limitations with BPs, not with Dmab
GI (swallowing disorders, inability to remain upright, esophageal stricture, gastroparesis, bariatric surgery) – Oral BPs should not be used
AFF – Consider BP holiday under appropriate circumstances (not for other drug classes)
Clotting disorders – avoid ET and RLX
High risk of osteosarcoma (XRT to skeleton, unexplained high alk phos, etc) – avoid TPT, Abalo
Personal opinion.

24. Postmenopausal Women Treated with Oral BP ≥ 5 Years or IV BP ≥ 3 Years
Low fracture risk
Definition: hip T-score > -2.5 and no hip, spine, or multiple osteoporotic fracture before or during therapy
Suggestion: consider drug holiday of 2-3 years
High fracture risk
Definition: hip T-score ≤ -2.5 or hip, spine, or multiple osteoporotic fracture before or during therapy
Suggestion: consider continuing oral BP up to 10 years and IV BP up to 6 years
Adler RA et al. J Bone Miner Res. 2016;31:16–35.

25. USA Participants: 21 Months
Bone Health
USA Participants: 21 Months
263 registered, 221 attended at least once, attendees each week
Other countries
Canada
Mexico
Chile
Brazil
Trinidad and Tobago
Ireland UK
Register at

26. 95 year-old woman with osteoporosis competes in powerlifting contest: curled 33 lbs, bench pressed 50 lbs, and deadlifted 82 lbs.