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  • that is not yet clinically available but has been studied in large prospective randomized clinical trials. TSECs appear to offer relief of vasomotor symptoms without inducing endometrial hyperplasia and without the breast stimulation seen with estrogens and/or progestogens. This promising new therapy may be available to the patient presented above at some point in the future.

Management of osteoporosis final Management of osteoporosis final Presentation Transcript

  • 05/01/10
  • Osteoporosis Definition
    • Systemic skeletal disease.
    • Low bone mass.
    • Microarchitectural deterioration of bone tissue.
    • Damage accumulation
    • Low strength
    • Increase in bone fragility.
    • Susceptibility to fracture.
    • Hip,spine,wrist ,ankle ,humerus
    05/01/10
  • Osteoporosis
    • A major health problem.
    • Consequences include - illness, pain, functional limitations, reduced quality of life, loss of independence, inability to work and even death.
    • 1 out of 3 women (33.3%) &1 out of 8 men (12.5%) suffer from osteoporosis related fracture in lifetime
    • Grave disease, highly under diagnosed and under treated.
    05/01/10
  • Diagnosis: x-ray -No
    • Insensitive
    • Apparent only after 50 -70 % reduction in bone mass
    • High radiation
    05/01/10
  • Bone Mineral Density
    • DEXA :DUAL Energy X-ray Absorptiometry-Gold standard
    • Single X-ray Absorptiometry /
    • Quantitative CT
    • ULTRASONIC BONE DENSITOMETER
      • Lower accuracy
      • No ionizing radiation
    GOLD STANDARD 05/01/10
  • WHO Classification Normal : BMD within 1 to -1 SD Osteopenia :BMD -1 - 2.5 SD Osteoporosis :BMD -2.5 SD or more 05/01/10
  • MANAGEMENT
    • Change of life style most important
    • Regular exercise must
    • Stop smoking and alcohol intake
    • If on steroids / phenytoin taken for long then alendronate must be given
    • Adequate exposure to sun
    05/01/10
  • CALCIUM AND VITAMIN D
    • Calcium and Vit D are main stay.
    • Calcium 1000 mg /day with SERM/Alendronate/HT
    • 1500 mg /day if no therapy
    • Calcium carbonate does not cause renal calculi
    • Vitamin D :Dose 400 IU < 70 yrs
    • 700 – 1000 IU > 70 yrs
    • CALCITRIOL
    • watch for Hypercalcemia / Hypercalciurea on long term use
    • No extra benefit for idiopathic postmenopausal osteoporosis
    05/01/10
  • Updated National Osteoporosis Foundation (NOF) guidelines 2008
    • After introduction of FRAX ® pharmacologic treatment is recommended for postmenopausal women over age 50 with
    • A hip or vertebral (clinical or morphometric) fracture.
    • T-score ≤ –2.5 at the femoral neck or spine after appropriate evaluation to exclude secondary causes.
    • Low bone mass (T-score between –1.0 and –2.5 at the femoral neck or spine) and a 10-year probability of a hip fracture ≥ 3% or a 10-year probability of any major osteoporosis-related fracture ≥ 20% based on US-adapted WHO absolute fracture risk model ( FRAX ® ).
    • NOF. Clinician’s Guide. 2008;1-36 .
    05/01/10
  • Drugs available and on horizons
    • Antiresoptives- Inhibit osteoclastic activity
    • HT
    • SERMS
    • Bishphosphonates
    • New drugs in pipeline
    • Anabolic stimulate bone fromation
    • PTH
    • Strontium
    • Flouride
    • IGF-1
    • PREVOS / SOTI / TROPOS
    • Tibolone
    • Statins
    05/01/10
  • ESTROGEN
    • • Women’s Health Initiative (WHI)
    • – 16,608 postmenopausal women
    • – E-P combination to assess CHD / breast CA
    • –  RR spine and hip fractures = 0.66
    • • Heart and Estrogen/progestin Replacement Study (HERS)- No reduction in fracture incidence
    05/01/10
  • HT
    • Indicated :
    • For relief of vasomotor symptoms
    • Urogenital symptoms
    • Not for prevention or treatment of osteoporosis .
    05/01/10
  • SERMS- RALOXIFENE (EVISTA®)
    • Raloxifene
    • Non-steroidal benzothiopene – binds Estrogen receptor, Inhibits bone resorption without stimulating endometrium
    • Multiple Outcomes of Raloxifene Evaluation (MORE)
    • - Studied 60 mg and 120 mg doses on patients with and without VCF(vertebral clinical fracture)
    • - 2.6%  BMD compared to placebo
    • - 30% (prior VCF) and 50% (no prior VCF) reduction in VCF
    • - RR of DVT = 3
    • - Significant reduction in incidence of breast CA
    05/01/10
  • SERM- Bazedoxifene
    • Bazedoxifene binds to both ERs with high affinity
    • Agonist on skeletal tissue, with bone turnover reduced by 20–25% with doses of 20 or 40 mg daily
    • Antagonist on breast tissue and uterine tissue
    • Side effects are hot flashes
    05/01/10
  • Selective Estrogen Receptor-ß Agonist, MF-101 ( 22 chinese herbal medicines)
    • MF-101-isolated active compounds, liquiritigen and chalcone, demonstrated selectivity for ER-ß
    • No effect on growth of breast cancer cells
    • No stimulation endometrium in Phase II trial
    • Effective in reducing the frequency and severity of hot flashes in postmenopausal women.
    • In order to confirm the safety and efficacy of MF-101, larger Phase III trials have been planned for 2009.
    05/01/10
  • TSEC & SERMS
    • An appealing alternative strategy is the use of a tissue-specific estrogen complex (TSEC). TSECs combine an estrogen and a SERM, taking advantage of the tissue-specific anti-estrogenic properties of the SERM in order to counteract the effects of estrogen on the uterus and breast. This combination, therefore, requires no progestogen.
    • Pinkerton JV, Utian W, Constantine G, Olivier MD, Pickar J. SMART-2: A phase III study of the efficacy and safety of bazedoxifene/conjugated estrogens for treatment of menopausal vasomotor symptoms. Proceedings and abstract. Menopause . 2007;14(Suppl. 2):1081.
    05/01/10
  • 05/01/10
  • BISPHOSPHONATES
    • Adverse effect
    • Poor intestinal absorption
    • N2 – containing
    • GI upset
    • Oesophagitis
    • Patient should remain upright ,take with a glass of water
    05/01/10
  • Alendronate (Bishphonate)
    • Non hormonal
    • FDA approved
    • For prevention as well as treatment
    • Increases BMD by 8.8% in lumbar spine and 6% in fracture NOF
    • 48% reduction in # NOF and spine fractures
    • Can be given for 5- 10 yrs or treatment free holidays can be givne.
    05/01/10
    • DOSE:daily or weekly
    • Except – very elderly and poor renal function
    • PREVENTION : 5mg per day,35 mg /week
    • Treatment : 10 mg/day , 70 mg/week
    • CARE
    • Empty stomach consumption
    • Calcium to be taken after 4 hrs
    • Longest duration tried – upto 5 yrs
    05/01/10
  • RISEDRONATE (ACTONEL®)
    • The Vertebral Efficacy with Risedronate
    • Therapy (VERT) Study
    • North American and Multinational Arms
    • Randomized, double-blind, placebo-controlled study of 2458 postmenopausal women c > 1 VCF
    • Treatment with 5mg/day for 3 years:
    • –  incidence of new VCF by 41%
    • -  BMD 5.4% vs. 1/1% (placebo)
    05/01/10
  • RISEDRONATE
    • Not recommended in patients with renal impairment
    • Contra Indications
      • Hypocalcaemia
      • Hypersensitivity
      • Inability to sit upright for 30 min.
    • Side Effects
    • Dysphagia
    • Esophagitis
    • Esophageal
    • Gastric ulcer
    05/01/10
  • CALCITONIN
    • • 32 amino acid polypeptide produced by the parafollicular “C” cells of the thyroid in response in plasma Calcium
    • • Binds to osteoclast cell receptor (-) effect)
    • • FDA approved for treatment but NOT prevention of
    • postmenopausal osteoporosis
    • Women > 5yrs after menopause
    • Consider in women with estrogen-dependent neoplasm, H/o DVT, renal insufficiency, or active GI pathology
    • Nasal spray (preferred) and injectable forms
    • Miacalcin®: 200 IU qd
    05/01/10
  • CALCITONIN
    • Prevent Recurrence of Osteoporotic Fracture Study (PROOF)
    • • 5-yr, multicenter, double-blind, randomized
    • study – 1255 patients
    • 817 pts c 1-5 previous VCF
    • Nasal spray salmon calcitonin (100, 200, 400 IU)
    • • 36% reduction in VCF (33% for entire group)
    • Lumbar BMD  1.2% during only 1st yr
    05/01/10
  • CALCITONIN
    • • Analgesic Effects
    • Analgesic for acute and chronic pain of VCF
    • Apparent by = 1 week
    • Mechanism likely a central effect (hypothalamus,PAG, dorsal horn)
    • Side Effects
    • Minimal: rhinitis, back/joint pain, HA
    • • Resistance
    • Antibodies in 20% PROOF patients
    05/01/10
  • CALCITONIN
    • INJECTABLE – 100 IU/day s/c BIOCALCIN
    • NASAL SPRAY 200 IU /day MIACALCIN
    • Inhibits osteoclast
    • Increases BMD by inhibiting osteoclast, decrease vertebral fractures
    • Good for pain in spinal fractures
    05/01/10
  • ANABOLIC AGENTS
    • PTH
    • Fluoride
    • IGF-1
    • Strontium
    • PREVOS / SOTI / TROPOS
    • Tibolone
    • Statins
    05/01/10
  • PTH
    • • Forteo
    • – Teriparatide = generic name
    • Synthetic teriparatide has been used in many clinical trials
    • Forteo is the recombinant DNA PTH 1-34 manufactured by Eli Lilly
    • Genetically engineered fragment of native PTH (84 amino acids)
    • FDA approved in US and Europe
    • • 24 month treatment period
    • – $ 600/month
    • A Recombinant DNA prep with all 84 amino acids (Preos) is in clinical trials
    05/01/10
  • PTH (Forteo) Neer et al. (2001) NEJM 344(19), 1434-1441
    • • Landmark Placebo controlled, randomized trial of 1637
    • postmenopausal women with prior vertebral fracture
    • 20µg vs 40µg Forteo
    • RR VCF = 0.35 for 20µg dose and 0.31 for 40µg
    • Lumbar spine BMD -  9%
    • Femoral neck BMD -  3%
    • Distal radius BMD -  2%
    05/01/10
  • PTH (Forteo)
    • Side Effects
    • Hypercalcemia (rare clinical significance)
    • Leg cramps, dizziness
    • Dose dependent increase in osteosarcoma in rats
    • None in 2000 Forteo patients
    • • Contraindications
    • Patients with open epiphysis
    • Paget disease
    • Prior skeletal malignancy
    • Metabolic bone diseases
    • Pre-existing hypercalcemia (Primary hyperparathyroidism)
    05/01/10
  • New Drug Denosumab
    • Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor- kB ligand (RANKL) that blocks its binding to RANK, inhibiting the development and activity of osteoclasts, decreasing bone resorption , and increasing bone density
    05/01/10
  • Dose of Denosumab
    • Denosumab given 60 mg subcutaneously twice yearly for 36 months associated with reduced risk of vertebral, nonvertebral and hip fractures in postmenopausal women with osteoporosis
    05/01/10
  • ORTHOSIS
    • ( A ) The posture training support vest contains 680 g (1.5 pound) weights to remind the patient to extend their thoracic spine.
    • ( B ) The Spinomed® brace consists of a back pad and strap system to strengthen the trunk muscle and improve posture.
    • ( C ) Hip protectors contain padding over the trochanters to help absorb the impact of a fall
    • Sinaki M et al . (2002) Stronger back muscles reduce the incidence of vertebral fractures: a prospective 10 year follow-up of postmenopausal women. Bone 30: 836–841
    05/01/10 dr.maninder AICOG2009 Improved back extensor strength correlate with decreased kyphosis and diminished vertebral fracture risk. Hip protectors don’t reduce incidence of hip fractures Van Schoor NM, Smit JH, Twisk JWR, et al. Prevention of hip fractures by external hip protectors: a randomized controlled trial. JAMA . 2003;289(15):1957–1962
  • FALL PREVENTION
    • Frailty and associated deconditioning;
    • Poor visual acuity;
    • Gait disturbances;
    • Impaired hearing;
    • Use of medications with that are sedating or compromise balance; and
    • Dangers in the environment, including loose rugs, lack of hand rails in the bathroom, etc.
    05/01/10 dr.maninder AICOG2009
  • To Summarise”Drugs for prevention&treatment”
    • Estrogens/only in early menopause and premature menopause
    • Alendronate- 5-10mg daily,35-70 mg /weekly
    • Risendronate daily2.5-5mg/day or weekly
    • Ibandronate 150 mg monthly,3 monthly
    • Zolendronic acid yearly 3mg I/V over 10-15min
    • Calcitonin nasal spray 200 IU daily
    • Raloxifene 60mg daily,lipid friendly ,lowers LDL
    • Teriparatide s/c20 – 40 µg/day .can be given*18-24months
    • Strontium ranelate 2 gm/day
    • Osteoprotegrin 3 mg/kg s/c N-Telopeptide decreases in 5day
    • Tibolone(not FDA approved for osteoporosis)
    • Progesterone and growth hormones are being studied&also flourides
    • ePocrates. Computerized pharmacology and prescribing reference. updated daily. Available at: ePocrates.com Accessed September 19, 2008 .
    05/01/10 dr.maninder AICOG2009
  • Lower Higher -2.5 BMD (T-score) Bisphosphonates Osteoporosis Therapy Algorithm Postmenopausal Women 05/01/10 Raloxifene PTH Calcitonin HRT HRT During Hot Flashes Post Vasomotor Symptoms Pre fracture Post Fracture Risk of Fracture AGE At Risk/Osteopenia Osteoporosis Severe Osteoporosis STAGE
  • OSTEOPOROSIS HIP FRACTURES 05/01/10
  • OSTEOPOROSIS HIP FRACTURES
    • Operate Early
    • High mortality &
    • morbidity by non-operative Treatment
    05/01/10
  • OSTEOPOROSIS SPINE FRACTURES
    • Acute # :
    • NSAIDS & rest
    • Calcitonin
    • Orthosis
    • Reduction in rate of bone loss
    • Reduction of rate of #
    05/01/10
  • 05/01/10
  • 05/01/10
  • Final Word
    • The real need in osteoporosis treatment is for additional anabolic agents
    • &quot;Our success or failure in combating osteoporosis increasingly depends not so much on the drugs available to us but rather on our ability to engage our patients and ensure that they take the medications we prescribe
    05/01/10
  • Final Message
    • ADD LIFE TOYEARS,
    • NOT YEARS TO LIFE.
    • “ AGE GRACEFULLY”
    05/01/10
  • ACKNOWLEDGEMENT
    • Dr.Sonal Bathla
    • MD,FICOG,FICMCH
    • SANT PARMANAND HOSPITAL
      • Dr. Shekhar Agarwal
      • Executive Director ,HOD of Orthopaedics
      • SANT PARMANAND HOSPITAL
    Dr.Maninder Ahuja Chairperson Geriatric Gynecology Committee FOGSI 05/01/10