Integral university, lucknow
Session:2019-2020
Project of :. Hospital training
Project on:. Osteoporosis and drug profile of
alendronate
Submitted by: Submitted to:
KAUSAL VERMA
Dr.Mohd.khustar
Pharm.D IV year. Assistant
professor
1601096009 Faculty of
pharmacy
Osteoporosis
Definition:
Osteoporosis is defined as a systemic skeletal disease characterised
by low bone mass and microarchitectural deterioration of bone
tissue leading to enhanced bone fragility and a consequent increase
in fracture risk.
Types:.
Two categories of osteoporosis have been identified:
1)primary osteoporosis:
Primary osteoporosis is the most common form of the disease and
includes-
I) postmenopausal osteoporosis (type I)
II) senile osteoporosis (type II).
2)Secondary osteoporosis:
Secondary osteoporosis is characterized as having a clearly definable
etiologic mechanism. Such as certain medicines and diseases state.
Causes/risk factors:
The leading cause of osteoporosis is a lack of certain hormones,
particularly estrogen in women and androgen in men.
Increase age
Inadequate intake of calcium and vitaminD
Smoking and alcohol consumption
Lack of physical activity
Certain drugs: thyroid hormones, phenobarbital
Disease states: renal disease, endocrine conditions
Family history
Symptoms:
There typically are no symptoms in the early stages of bone loss. But
once bones have been weakened by osteoporosis, might have signs
and symptoms that include:
Bone pain, caused by a fractured or collapsed vertebra
Loss of height over time
A stooped posture
bone that breaks much more easily than expected
Increased kyphosis
Distorted body image
Immobility
Loss of self-esteem
Neck, back pain
Diagnosis:
X-rays- determine bone density
Radiographic- bone mass
Ultrasonography-determine bone density
DEXA scan is mostly preferred which measure the bone
mineral density
DEXA scan gives a number called T-score which represents a average
bone mineral density.
If T-score is -1 or greater then normal
If T-score is -1 and -2.5 then osteopenia
If T-Score is -2.5 or less then osteoporosis.
Complication:
Spinal compression fractures
Kyphosis or dowager's hump
Height loss
Respiratory complication (breathing difficulty)
Cardiovascular complication
Loss of independence
Mood changes
Rarely, neurologic injury
Severe back pain
Management:.
A)Non-pharmacological management:
Diet/nutritional changes:
- Calcium rich diet (dairy products)
- Vitamin.D contributors
Lifestyle modification:
- Physical activity (exercise)
- Cessation of smoking, alcohol and high caffeine intake
- Adequate exposure to sunlight
- Appropriate reduction of medications
- Avoid environmental hazards
Use hip protector :prevents direct impact on pelvis
B)pharmacological management:
1)Estrogen/progestin therapy
2)Selective estrogen receptor modulators(SERMs)
Eg: Raloxifene , tamoxifen
3)Bisphosphonates
Eg: Alendronate, Risedronate, ibandronate, zoledronic acid
4)Calcitonin
5)Parathyroid hormones
6)Biologic agents: Denosumab
Alendronate:-
IUPAC name: sodium [4-amino-1-hydroxy-1-(hydroxy-oxido-
phosphoryl)- butyl] phosphonic acid trihydrate
Formula:C4H13NO7P2
Molar mass: 249.097 g
Mechanism of action:
Alendronate inhibits osteoclast-mediated bone-resorption. Like all
bisphosphonates, it is chemically related to inorganic pyrophosphate.
alendronate specifically inhibits bone resorption . Its inhibition of
bone-resorption is dose-dependent .
Pharmacokinetic data:-
Bioavailability:0.6%
Metabolism: excreted unchanged
Elimination half-life: 126 months
Excretion: Kidney
Usual adult dose for osteoporosis:
-10 mg orally once a day or 70 mg orally once a week.
-For the Treatment of Glucocorticoid-Induced Osteoporosis: 5 mg orally
OD .
-For the treatment of glucocorticoid in Postmenopausal Women Not Receiving
Estrogen: 10 mg orally once a day
Side effects of alendronate:
Acid regurgitation
Flatulence
Heartburn
Diarrhoea
Constipation
Nausea
Dyspepsia
Gastritis
Abdominal distension
Redness of skin
Loosening of teeth
Blurred vision
Muscle cramps
Tingling of hands and feet
Drug interaction :
Antacids and some vitamins
aspirin
Nonsteroidal Anti-Inflammatory (NSAID) medicines
Contraindication:
Alendronate is contraindicated in patients with the following
conditions:
Abnormalities of the esophagus which delay esophageal
emptying such as stricture or achalasia.
Inability to stand or sit upright for at least 30 minutes.
Do not administer Alendronate oral solution to patients at
increased risk of aspiration.
Hypocalcemia .
Ten available brands (alendronate ) of reputed pharma
company:.
Company : Brands: price for 10mg tab/10tab:
1)WEST COAST:- ALANT tab. -
2)MACLEODS:- ALENOST tab. Rs.49
3)TROIKA:- BIFOSA tab. Rs.50
4)DR.REDDY'S:- DENFOS tab. Rs.49.7
5)CIPLA:- OSTEOFOS tab. Rs.54.84
6)RANBAXY:-. RALENOST tab. Rs.49.5
7)SUN-PHARMA:- RESTOFOS tab. Rs.58.8
8)KHANDELWAL:- ZOPHOST tab. Rs.40
9)MERCK:- ZOSAMAX tab. -
10)VINTAGE LAB:- ALENDIX tab. -
11)SWISS PHARMA:- OSTOGEE tab. -
12)FINECURE PHARMA:- PORONIL tab. Rs.49.5
Most utilized brand: MERCY (ZOSAMAX)
Cheapest brand: KHANDELWAL (ZOPHOST)
DOSAGE FORM:
- An oral tablet
- An oral solution
- An oral effervescent tablet
Conclusion:
Osteoporosis is systemic skeletal disease which is characterized by
low bone mass and enhance bone fragility Alendronate is also a drug
used in osteoporosis which comes under the category of
bisphosphonate .Take at least 30 min before food. Alendronate
interacts with antacids, vitamins and with aspirin so they should not
be taken at a time. Do not lay down after taking this medicine
(oesophageal damage). Do not take at bed time.
