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ISBMR osteoporosis
guidelines
Dr. Shinjan Patra
Introduction
• Characterized by low bone mass and micro-
architectural deterioration of bone tissue,
with a consequent increase in bone fragility
and susceptibility to fracture
• 1 in 3 women over age 50 experience
osteoporotic fractures, as 1 in 5 men over age
50
Indian Scenario
• Prevalence of osteoporosis ranging from 8 to
62% in Indian women of different age groups
• Ranging from 8.5 to 24.6% in males older than
50 years
• F:M ratio of about 3:1 regarding fractures
• Urbanization leads to increased prevalence
• Low awareness
DXA in India
• 0.26 per million
• Judicious use of DXA facilities
Indications of DXA measurement
• Women > 60 + men> 65 regardless of clinical risk factors
• Postmenopausal women < 60 and men aged 50–64 years
when there are concerns for osteoporosis based on their
clinical risk factor profile
• Women in the menopausal transition if there is a specific
risk factor associated with increased fracture risk, such as
low body weight, prior low-trauma fracture, or high-risk
medication
• Individuals who have had a fragility fracture before the age
of 50 years
• Individuals with a condition (e.g., rheumatoid
arthritis, diabetes mellitus, malabsorption
syndrome) or who are taking medication (e.g.,
glucocorticoids in a daily dose ≥ 5 mg
prednisone or equivalent for ≥ 3 months)
associated with low bone mass or bone loss
• Any individual being considered for
pharmacologic therapy for osteoporosis
T-score calculation
• Caucasian female database derived from the
NHANES III
BTM
• Dynamic parameters that reflect short-term,
acute changes in bone remodeling status
• No role in the diagnosis of osteoporosis
• Baseline BTM level estimated prior to
initiation of therapy for subsequent
comparison during follow-up
• P1NP/CTX recommended
Screening tools (Indians)
• SCORE (Simple Calculated Osteoporosis Risk
Estimation) (value > 6 having good sensitivity)
• OSTA (osteoporosis self-assessment tool for
Asians)
• MORES (male osteoporosis risk estimation
score)
Pharmacological T/t
General Advice
• Limit alcohol intake to no more than 2 units per
day
• Stop smoking
• Maintain an active lifestyle, including weight-
bearing and balance exercises
• Counseling on reducing the risk of falls,
particularly among older patients
Vit D + Calcium
• 25 (OH) D > 20 ng/ml
• 1000 to 2000 (IU) of daily maintenance
therapy
• Adequate dietary intake of calcium with a
total intake (including diet plus supplement, if
needed) of at least 1000 mg/day
Therapy for prevalent VF
• Teriparatide : 24 months of therapy followed
by Anti-Resorptives
• Inj Zoledronic acid for 3-5 years
• Oral BPN
Therapy for prevalent HF
• IV Zoledronic
• Denosumab
Therapy without prevalent F (high risk)
• Oral/IV BPN
(Alendronate/Risedronate/Zoledronic)
• Denosumab
• Teriparatide ( T < -3.5)
Therapy without prevalent F
(low/moderate risk)
• BPN
• Denosumab
In CKD/HD
• BPN C/I in stage IV/V
• Denosumab : risk of Hypocalcemia
• Adynamic bone disease
HRT
• Not recommended
• Testosterone in hypogonadal male ( T < 200
ng/dl)
Intranasal calcitonin
• For temporary bone pain relief
• Only in women who cannot tolerate standard
T/t options
Combination therapies
• Denosumab + Teriparatide ( data’s
inadequate)
Sequential therapies
• Denosumab f/b BPN
• TP F/b Denosumab/BPN
• Unresponsive to anti-resorptive: TP + Anti-
Resorptives
Frequency of FU
• 3 months after initiation & then 3-6 monthly
• Annual thereafter
Check lists
• History : Falls; Bone/jaw pain
• Physical : Spine examination
• Vit D : 6 monthly f/b annually
• Ca: 12h after Teriparatide;
• DXA : 1-2 yearly- Increase above the LSC (changes
in LS robust than FN)
• BTM : For PINP, a threshold of > 20% or > 10 μg/L
and decrease in CTx by at least 30% or by at least
100 ng/L
Drug Holiday
• Matter of debate
• Only in Low/moderate risk groups
Existing other guidelines and
literatures
Difference with Endocrine society
guidelines
Endocrine Society Guidelines ISMBR guidelines
BMD DXA indications NOF
Female > 65, Male > 70
Female < 65 with RF for
fractures
Female > 60, Male > 65
Female < 65 with RF for
fractures
HRT Usage of Raloxifene,
Bazedoxifene , Tibolone
No mentioning of these
Classification Differentiates into Vertebral and
Non-vertebral
Differentiates into
prevalent and non-
prevalent fractures
Vit-D threshold At least 30 ng/ml At least 20 ng/ml
Reduced the risk of new radiographic vertebral fracture, with a cumulative
incidence of 2.3% in the denosumab group, versus 7.2% in the placebo group;
relative decrease of 68%
Reduced the risk of hip fracture, with a cumulative incidence of 0.7% in the
denosumab group, versus 1.2% in the
placebo group; relative decrease of 40%
Reduced the risk of non-vertebral fracture by 20%
Discontinuation increases bone turnover markers 3 months after a scheduled
dose is omitted, reaching above-baseline levels by 6 months, and decreases
bone mineral density (BMD) to baseline levels by 12 months
The vertebral fracture rate increased upon denosumab discontinuation to the
level observed in untreated participants
A majority of participants who sustained a vertebral fracture after
discontinuing denosumab had multiple vertebral fractures, with greatest risk in
participants with a prior vertebral fracture
Therefore, patients who discontinue denosumab should rapidly transition to an
alternative antiresorptive treatment
Women received 2-years of either teriparatide, denosumab or both medications
followed by 2- years of the alternate therapy (women who received combination
therapy initially received an additional 2-years of denosumab alone)
In the 22 women not receiving follow-up therapy, femoral neck, total hip, and
spine BMD decreased by −4.2±4.3%,−4.5±3.6%, and−10.0±5.4%, respectively,
while BMD was maintained in those who did receive follow-up antiresorptive
drugs
Among untreated women, femoral neck BMD decreased more in those
discontinuing denosumab (−5.8 ± 4.0%) than in those discontinuing teriparatide
(−0.8±2.6%, P=0.008)
Observational randomized comparative 1 year study was undertaken
to evaluate the adherence/compliance rates of most commonly prescribed daily alendronate (ALN),
weekly risedronate (RIS) and monthly ibandronate (IBN) BP regimens
Numerically maximum adherence rate of 56% was recorded in monthly
BP regimen followed by weekly (36%) and daily regimen (32%)
Concomitant treatment for co-morbid condition (57.14%), unawareness about osteoporosis (OP)
(50%), cost of treatment (45.33%), belief that drugs is for their general disability (39.28%),
physician’s failure to stress the need and necessary calcium + vitamin D daily requirement (23.80%)
each were the most prevalent factors responsible for non-adherence
Thank you……..

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ISBMR osteoporosis guidelines

  • 2.
  • 3. Introduction • Characterized by low bone mass and micro- architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture • 1 in 3 women over age 50 experience osteoporotic fractures, as 1 in 5 men over age 50
  • 4. Indian Scenario • Prevalence of osteoporosis ranging from 8 to 62% in Indian women of different age groups • Ranging from 8.5 to 24.6% in males older than 50 years • F:M ratio of about 3:1 regarding fractures • Urbanization leads to increased prevalence • Low awareness
  • 5. DXA in India • 0.26 per million • Judicious use of DXA facilities
  • 6.
  • 7. Indications of DXA measurement • Women > 60 + men> 65 regardless of clinical risk factors • Postmenopausal women < 60 and men aged 50–64 years when there are concerns for osteoporosis based on their clinical risk factor profile • Women in the menopausal transition if there is a specific risk factor associated with increased fracture risk, such as low body weight, prior low-trauma fracture, or high-risk medication • Individuals who have had a fragility fracture before the age of 50 years
  • 8. • Individuals with a condition (e.g., rheumatoid arthritis, diabetes mellitus, malabsorption syndrome) or who are taking medication (e.g., glucocorticoids in a daily dose ≥ 5 mg prednisone or equivalent for ≥ 3 months) associated with low bone mass or bone loss • Any individual being considered for pharmacologic therapy for osteoporosis
  • 9. T-score calculation • Caucasian female database derived from the NHANES III
  • 10.
  • 11. BTM • Dynamic parameters that reflect short-term, acute changes in bone remodeling status • No role in the diagnosis of osteoporosis • Baseline BTM level estimated prior to initiation of therapy for subsequent comparison during follow-up • P1NP/CTX recommended
  • 12.
  • 13. Screening tools (Indians) • SCORE (Simple Calculated Osteoporosis Risk Estimation) (value > 6 having good sensitivity) • OSTA (osteoporosis self-assessment tool for Asians) • MORES (male osteoporosis risk estimation score)
  • 15. General Advice • Limit alcohol intake to no more than 2 units per day • Stop smoking • Maintain an active lifestyle, including weight- bearing and balance exercises • Counseling on reducing the risk of falls, particularly among older patients
  • 16. Vit D + Calcium • 25 (OH) D > 20 ng/ml • 1000 to 2000 (IU) of daily maintenance therapy • Adequate dietary intake of calcium with a total intake (including diet plus supplement, if needed) of at least 1000 mg/day
  • 17. Therapy for prevalent VF • Teriparatide : 24 months of therapy followed by Anti-Resorptives • Inj Zoledronic acid for 3-5 years • Oral BPN
  • 18. Therapy for prevalent HF • IV Zoledronic • Denosumab
  • 19. Therapy without prevalent F (high risk) • Oral/IV BPN (Alendronate/Risedronate/Zoledronic) • Denosumab • Teriparatide ( T < -3.5)
  • 20. Therapy without prevalent F (low/moderate risk) • BPN • Denosumab
  • 21. In CKD/HD • BPN C/I in stage IV/V • Denosumab : risk of Hypocalcemia • Adynamic bone disease
  • 22. HRT • Not recommended • Testosterone in hypogonadal male ( T < 200 ng/dl)
  • 23. Intranasal calcitonin • For temporary bone pain relief • Only in women who cannot tolerate standard T/t options
  • 24. Combination therapies • Denosumab + Teriparatide ( data’s inadequate)
  • 25. Sequential therapies • Denosumab f/b BPN • TP F/b Denosumab/BPN • Unresponsive to anti-resorptive: TP + Anti- Resorptives
  • 26. Frequency of FU • 3 months after initiation & then 3-6 monthly • Annual thereafter
  • 27. Check lists • History : Falls; Bone/jaw pain • Physical : Spine examination • Vit D : 6 monthly f/b annually • Ca: 12h after Teriparatide; • DXA : 1-2 yearly- Increase above the LSC (changes in LS robust than FN) • BTM : For PINP, a threshold of > 20% or > 10 μg/L and decrease in CTx by at least 30% or by at least 100 ng/L
  • 28. Drug Holiday • Matter of debate • Only in Low/moderate risk groups
  • 29. Existing other guidelines and literatures
  • 30.
  • 31.
  • 32. Difference with Endocrine society guidelines Endocrine Society Guidelines ISMBR guidelines BMD DXA indications NOF Female > 65, Male > 70 Female < 65 with RF for fractures Female > 60, Male > 65 Female < 65 with RF for fractures HRT Usage of Raloxifene, Bazedoxifene , Tibolone No mentioning of these Classification Differentiates into Vertebral and Non-vertebral Differentiates into prevalent and non- prevalent fractures Vit-D threshold At least 30 ng/ml At least 20 ng/ml
  • 33.
  • 34.
  • 35.
  • 36. Reduced the risk of new radiographic vertebral fracture, with a cumulative incidence of 2.3% in the denosumab group, versus 7.2% in the placebo group; relative decrease of 68% Reduced the risk of hip fracture, with a cumulative incidence of 0.7% in the denosumab group, versus 1.2% in the placebo group; relative decrease of 40% Reduced the risk of non-vertebral fracture by 20%
  • 37. Discontinuation increases bone turnover markers 3 months after a scheduled dose is omitted, reaching above-baseline levels by 6 months, and decreases bone mineral density (BMD) to baseline levels by 12 months The vertebral fracture rate increased upon denosumab discontinuation to the level observed in untreated participants A majority of participants who sustained a vertebral fracture after discontinuing denosumab had multiple vertebral fractures, with greatest risk in participants with a prior vertebral fracture Therefore, patients who discontinue denosumab should rapidly transition to an alternative antiresorptive treatment
  • 38.
  • 39.
  • 40. Women received 2-years of either teriparatide, denosumab or both medications followed by 2- years of the alternate therapy (women who received combination therapy initially received an additional 2-years of denosumab alone) In the 22 women not receiving follow-up therapy, femoral neck, total hip, and spine BMD decreased by −4.2±4.3%,−4.5±3.6%, and−10.0±5.4%, respectively, while BMD was maintained in those who did receive follow-up antiresorptive drugs Among untreated women, femoral neck BMD decreased more in those discontinuing denosumab (−5.8 ± 4.0%) than in those discontinuing teriparatide (−0.8±2.6%, P=0.008)
  • 41. Observational randomized comparative 1 year study was undertaken to evaluate the adherence/compliance rates of most commonly prescribed daily alendronate (ALN), weekly risedronate (RIS) and monthly ibandronate (IBN) BP regimens Numerically maximum adherence rate of 56% was recorded in monthly BP regimen followed by weekly (36%) and daily regimen (32%) Concomitant treatment for co-morbid condition (57.14%), unawareness about osteoporosis (OP) (50%), cost of treatment (45.33%), belief that drugs is for their general disability (39.28%), physician’s failure to stress the need and necessary calcium + vitamin D daily requirement (23.80%) each were the most prevalent factors responsible for non-adherence