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8/15/2017 1
Ibandronate Sodium
Some Basics
By
Rana Khurram Shahzad
Product Manager
Contents
• Bone
• Types of bones
• Functions of bones
• Diseases of bones
• Treatment options
8/15/2017 3
8/15/2017 4
Bone
Human Skelton
8/15/2017 5
• Bone is made up of Osseous tissue,
cartilage, dense connective tissue,
epithelium, adipose tissue.
• The entire framework of bones and
cartilages constitute the “Skeletal
System”.
8/15/2017 6
STRUCTURE OF BONE
8/15/2017 7
8/15/2017 8
Bone has both Organic and Inorganic
components
Organic part - consists mainly of protein
collagen & specialized cells called
osteoclasts, osteoblasts, and osteocytes
Inorganic part - consists mainly of calcium
phosphate.
Composition of bone
8/15/2017 9
8/15/2017 10
TYPES OF BONES
There are 270 bones at the time of birth
this total then decreases to 206 bones by
adulthood after some bones fused
together.
Human Skeleton divided in two parts
1. Axial Skeleton
2. Appendicular Skeleton
8/15/2017 11
LONG BONES
SHORT BONES
FLAT BONES
IRREGULAR BONES
SESAMOID BONES
TYPES OF BONES
8/15/2017 12
FUNCTIONS OF BONE
• Support
• Protection
• Assists movement
• Mineral storage
• Hematopoiesis
8/15/2017 13
Types of bone tissue
• Compact bone tissue
(OsseousTissue)
• Spongy bone tissue
8/15/2017 14
BONE CELLS
Four types of cells:
• Osteogenic cells
• Osteoblasts
• Osteocytes
• Osteoclasts
8/15/2017 Template copyright 2005 www.brainybetty.com 15
8/15/2017 16
Some BONES related
Diseases
1- Arthritis
2- Bursitis
3- Tendonitis
4- Osteoporosis
5- Scoliosis
6- Spine TB
7- Rickets
8- Gout
9- Acromegaly
10- Poliomyelitis
11- Spina Bifida
12- Club foot
13- Bone Cancer(Sarcoma, Myeloma,
Leukemia)
8/15/2017 17
Osteoporosi
s
8/15/2017 18
Osteoporosis:
Is a systemic skeletal
disease characterized
by low bone density
and
microarchitectural
deterioration of bone
tissue with a
consequent increase
in bone fragility
8/15/2017 19
Difference of Normal &
Osteoporotic BONES
8/15/2017 20
Osteoporosis is 3 time more
common in women then in men,
because women have lower peak
bone mass and hormonal
changes at the time of
menopause
8/15/2017 21
Approximately 1 in 2 women and 1 in
4 men over age 50 will have an
osteoporosis related fracture in their
remaining lifetime.
8/15/2017 22
Causes of Osteoporosis
• Being female
• Older age
• Family history of osteoporosis.
• History of broken bones
• Low sex hormones
– Low estrogen levels in women, including
menopause
– Missing periods (amenorrhea)
– Low levels of testosterone in male.
8/15/2017 23
• Diet
– Low calcium intake
– Low vitamin D intake
– Excessive intake of
protein, sodium and
caffeine
• Inactive lifestyle
• Smoking , Alcohol abuse
8/15/2017 24
• Certain medications
– steroid, anticonvulsants etc
• Certain diseases
–anorexia nervosa, rheumatoid
arthritis, gastrointestinal diseases and
others
8/15/2017 25
8/15/2017 26
Diagnosis
8/15/2017 27
Diagnosis
BMD test is done to diagnose and
predict fracture risk and to monitor
therapy.
T score Category
> -1 Normal
< -1 to > 2.5 Osteopenia
<-2.5 Osteoporosis
<-2.5 with
fragility fracture
Established/severe
osteoporosis
8/15/2017 28
Treatment Options
 Bisphosphonates.
 Strontium ranelate.
 Selective oestrogen receptor modulators (SERMs)
 Parathyroid hormone (teriparatide)
 Calcium and vitamin D supplements.
 Hormone replacement therapy (HRT)
 Testosterone treatment
BISPHOSPHONATE
Bisphosphonates are
a class of drugs that
prevent the loss
of bone mass, used to
treat osteoporosis and
similar diseases. They are
the most commonly
prescribed drugs used to
treat osteoporosis
8/15/2017 30
• Indications for bisphosphonates include such
conditions
1. Postmenopausal
2. Glucocorticoid-induced osteoporosis,
3. Paget’s disease,
4. Osteolytic and osteoblastic bone metastases,
5. Fibrous dysplasia,
6. Heterotopic ossification,
7. Myositis ossificans.
8. Other bisphosphonates, medronate (R1, R2 = H) and
oxidronate (R1 = H, R2 = OH) are mixed with radioactive
technetium and are injected for imaging bone and detecting
bone disease
8/15/2017 31
NON-NITROGENOUS
Olpadronate
NITROGENOUS
Tiludronate
Clodronate
Etidronate
Alendronate
Neridronate
Pamidronate
Risedronate
Ibandronate
8/15/2017 32
(Ibandronate Sodium) inhibits
osteoclast activity and reduces
bone resorption and turnover
Mechanism of Action
8/15/2017 33
Pharmacokinetics
 Absorption
The absorption of oral ibandronate occurs in
the upper gastrointestinal tract.
 Distribution
After absorption, ibandronate rapidly binds to
bone. In vitro protein binding in human
serum was 99.5% to 90.9%.
8/15/2017 34
 Elimination
The portion of ibandronate that is not removed from
the circulation via bone absorption is eliminated
unchanged
by the kidney (approximately 50% to 60% of the
absorbed dose). Unabsorbed ibandronate is eliminated
unchanged in the feces.
 Metabolism
Ibandronate does not undergo hepatic
metabolism and does not inhibit the
hepatic cytochrome P450 system.
8/15/2017 35
(Ibandronate Sodium) is a
bisphosphonate indicated for the
treatment and prevention of
osteoporosis.
Indications
8/15/2017 36
DOSAGE AND ADMINISTRATION
The dose of Ibandronate is 150 mg ONE
tablet taken once monthly on the same
date each month.
8/15/2017 37
Important Administration Instructions
• Take Ibandronate at least 60 minutes before
the first food or drink (other than water) of the
day or before taking any oral medication or
supplementation including calcium, antacids,
or vitamins to maximize absorption and clinical
benefit.
• Avoid the use of water with supplements
including mineral water because they may
have a higher concentration of calcium.
8/15/2017 38
• Swallow Ibandronate tablet whole with
a full glass of plain water while
standing or sitting in an upright position
to reduce the potential for esophageal
irritation.
• Avoid lying down for 60 minutes after
taking Ibandronate.
• Do not eat, drink anything except plain
water, or take other medications for at
least 60 minutes after taking
Ibandronate.
8/15/2017 39

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Ibandronate and osteoporosis treatment and bones

  • 2. Ibandronate Sodium Some Basics By Rana Khurram Shahzad Product Manager
  • 3. Contents • Bone • Types of bones • Functions of bones • Diseases of bones • Treatment options 8/15/2017 3
  • 5. 8/15/2017 5 • Bone is made up of Osseous tissue, cartilage, dense connective tissue, epithelium, adipose tissue. • The entire framework of bones and cartilages constitute the “Skeletal System”.
  • 8. 8/15/2017 8 Bone has both Organic and Inorganic components Organic part - consists mainly of protein collagen & specialized cells called osteoclasts, osteoblasts, and osteocytes Inorganic part - consists mainly of calcium phosphate. Composition of bone
  • 10. 8/15/2017 10 TYPES OF BONES There are 270 bones at the time of birth this total then decreases to 206 bones by adulthood after some bones fused together. Human Skeleton divided in two parts 1. Axial Skeleton 2. Appendicular Skeleton
  • 11. 8/15/2017 11 LONG BONES SHORT BONES FLAT BONES IRREGULAR BONES SESAMOID BONES TYPES OF BONES
  • 12. 8/15/2017 12 FUNCTIONS OF BONE • Support • Protection • Assists movement • Mineral storage • Hematopoiesis
  • 13. 8/15/2017 13 Types of bone tissue • Compact bone tissue (OsseousTissue) • Spongy bone tissue
  • 14. 8/15/2017 14 BONE CELLS Four types of cells: • Osteogenic cells • Osteoblasts • Osteocytes • Osteoclasts
  • 15. 8/15/2017 Template copyright 2005 www.brainybetty.com 15
  • 16. 8/15/2017 16 Some BONES related Diseases 1- Arthritis 2- Bursitis 3- Tendonitis 4- Osteoporosis 5- Scoliosis 6- Spine TB 7- Rickets 8- Gout 9- Acromegaly 10- Poliomyelitis 11- Spina Bifida 12- Club foot 13- Bone Cancer(Sarcoma, Myeloma, Leukemia)
  • 18. 8/15/2017 18 Osteoporosis: Is a systemic skeletal disease characterized by low bone density and microarchitectural deterioration of bone tissue with a consequent increase in bone fragility
  • 19. 8/15/2017 19 Difference of Normal & Osteoporotic BONES
  • 20. 8/15/2017 20 Osteoporosis is 3 time more common in women then in men, because women have lower peak bone mass and hormonal changes at the time of menopause
  • 21. 8/15/2017 21 Approximately 1 in 2 women and 1 in 4 men over age 50 will have an osteoporosis related fracture in their remaining lifetime.
  • 22. 8/15/2017 22 Causes of Osteoporosis • Being female • Older age • Family history of osteoporosis. • History of broken bones • Low sex hormones – Low estrogen levels in women, including menopause – Missing periods (amenorrhea) – Low levels of testosterone in male.
  • 23. 8/15/2017 23 • Diet – Low calcium intake – Low vitamin D intake – Excessive intake of protein, sodium and caffeine • Inactive lifestyle • Smoking , Alcohol abuse
  • 24. 8/15/2017 24 • Certain medications – steroid, anticonvulsants etc • Certain diseases –anorexia nervosa, rheumatoid arthritis, gastrointestinal diseases and others
  • 27. 8/15/2017 27 Diagnosis BMD test is done to diagnose and predict fracture risk and to monitor therapy. T score Category > -1 Normal < -1 to > 2.5 Osteopenia <-2.5 Osteoporosis <-2.5 with fragility fracture Established/severe osteoporosis
  • 28. 8/15/2017 28 Treatment Options  Bisphosphonates.  Strontium ranelate.  Selective oestrogen receptor modulators (SERMs)  Parathyroid hormone (teriparatide)  Calcium and vitamin D supplements.  Hormone replacement therapy (HRT)  Testosterone treatment
  • 29. BISPHOSPHONATE Bisphosphonates are a class of drugs that prevent the loss of bone mass, used to treat osteoporosis and similar diseases. They are the most commonly prescribed drugs used to treat osteoporosis
  • 30. 8/15/2017 30 • Indications for bisphosphonates include such conditions 1. Postmenopausal 2. Glucocorticoid-induced osteoporosis, 3. Paget’s disease, 4. Osteolytic and osteoblastic bone metastases, 5. Fibrous dysplasia, 6. Heterotopic ossification, 7. Myositis ossificans. 8. Other bisphosphonates, medronate (R1, R2 = H) and oxidronate (R1 = H, R2 = OH) are mixed with radioactive technetium and are injected for imaging bone and detecting bone disease
  • 32. 8/15/2017 32 (Ibandronate Sodium) inhibits osteoclast activity and reduces bone resorption and turnover Mechanism of Action
  • 33. 8/15/2017 33 Pharmacokinetics  Absorption The absorption of oral ibandronate occurs in the upper gastrointestinal tract.  Distribution After absorption, ibandronate rapidly binds to bone. In vitro protein binding in human serum was 99.5% to 90.9%.
  • 34. 8/15/2017 34  Elimination The portion of ibandronate that is not removed from the circulation via bone absorption is eliminated unchanged by the kidney (approximately 50% to 60% of the absorbed dose). Unabsorbed ibandronate is eliminated unchanged in the feces.  Metabolism Ibandronate does not undergo hepatic metabolism and does not inhibit the hepatic cytochrome P450 system.
  • 35. 8/15/2017 35 (Ibandronate Sodium) is a bisphosphonate indicated for the treatment and prevention of osteoporosis. Indications
  • 36. 8/15/2017 36 DOSAGE AND ADMINISTRATION The dose of Ibandronate is 150 mg ONE tablet taken once monthly on the same date each month.
  • 37. 8/15/2017 37 Important Administration Instructions • Take Ibandronate at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation including calcium, antacids, or vitamins to maximize absorption and clinical benefit. • Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium.
  • 38. 8/15/2017 38 • Swallow Ibandronate tablet whole with a full glass of plain water while standing or sitting in an upright position to reduce the potential for esophageal irritation. • Avoid lying down for 60 minutes after taking Ibandronate. • Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking Ibandronate.