Management of Osteoporosis and Bone Pain Calcitonin Nasal Spray-Calcispray

Management of Osteoporosis and Bone pain
with
CALCITONIN NASAL SPRAY-CALCISPRAY

CALCITONIN
• Calcitonin is a polypeptide hormone secreted by the

parafollicular cells of the thyroid gland in mammals.
• The active ingredient in calcitonin-salmon (rDNA
origin) Nasal Spray is a polypeptide of 32 amino
acids manufactured by recombinant DNA
technology and is identical to calcitonin-salmon
produced by chemical synthesis.
WHY SALMON ?
• Human
• Pork
• Salmon
40- 50 times more potent than

human calcitonin
WHY NASAL ROUTE ?
• Ease of drug administration, Sp for older Pts

• Better patient compliance
• No risk of infections (with parenteral route)
• Satisfactory nasal absorption
• Good tolerance of nasal mucosa with minimal local side effects
CALCITONIN AND OSTEOPOROSIS
• Calcitonin decrease in the rate of bone resorption.

• Histologically, this is associated with a decreased
number of osteoclasts and an apparent decrease in
their resorptive activity.
• In vitro studies have shown that calcitonin-salmon
causes inhibition of osteoclast function with loss of
the ruffled osteoclast border responsible for
resorption of bone.
CALCITONIN AND BONE PAIN
• Bone pain is a symptom frequently associated with bone disease

characterized by enhanced bone resorption, such as Paget’s bone
disease, metastatic bone disease, and osteoporotic syndromes.
• The analgesic effect can be evident as soon as the second week of

treatment.
• Calcitonin and morphineinduced analgesia, and reports of calcitonin-

induced elevation of plasma endorphin levels, suggest the possible
involvement of the endogenous opiate system in mediating the
analgesic action of calcitonin.
• However, the demonstration of calcitonin binding sites in areas of the

brain involved in pain perception and a series of animal studies have
raised the possibility that calcitonin may directly modulate nociception
in the central nervous system .
•
Osteoporos Int. 2002 Nov;13(11):858-67 .
INDICATIONS
• Osteoporosis : The recommended dosage of

calcitonin spray for the treatment of established
post-menopausal osteoporosis is 200 IU once a
day administered intranasally, alternating nostrils
daily.
• Use of calcitonin (salmon) nasal spray is
recommended in conjunction with an adequate
calcium (at least 1000 mg elemental calcium) and
vitamin D (400 IU per day) intake to prevent
progressive loss of bone mass.
INDICATIONS
• Bone pain associated with osteolysis and/or

osteopenia : 200-400 IU daily. Up to 200 IU may
be administered as a single dose; in cases where a
higher dosage is required it should be given in
divided doses.
• Prevention and treatment of fractures: The
recommended dosage of calcitonin spray for the
treatment of fractures is 200 IU once a day
administered intranasally, alternating nostrils
daily.
CONTRAINDICATIONS
• Hypersensitivity to synthetic calcitonin (salmon) or to any of the

excipients of the formulation
HOW IT SHOULD BE TAKEN?
• It should be administered as 1 spray per day into a nostril, alternating

the nostrils every day.
SIDE EFFECTS :
Salmon calcitonin may cause allergic reactions, runny nose, bleeding

from the nose and sinusitis..
PREGNANCY & NURSING MOTHERS
• Category C.
• It is not known whether this drug is excreted in human milk. As a
general rule, nursing should not be undertaken while a patient is on
this drug since many drugs are excreted in human milk.
OVERDOSAGE
• No instances of overdose with calcitonin-salmon

nasal spray have been reported and no serious
adverse reactions have been associated with high
doses.
• Single doses of calcitonin-salmon nasal spray up
to 1600 International Units, doses up to 800
International Units per day for 3 days and chronic
administration of doses up to 600 International
Units per day have been studied without serious
adverse effects.
CLINICAL EVIDENCES
THE EVIDENCE: QUEST STUDY
• Ninety-one postmenopausal osteoporotic women were

followed for 2 years (n = 46 for CT-NS, n = 45 for
placebo); all women received 500 mg calcium daily.
• MRI measurements at distal radius, hip , and os calcis
(obtained yearly), iliac crest bone biopsies with 2D
histomorphometry and 3D microCT (obtained at study
onset and conclusion), DXA-BMD at spine/hip/wrist/os
calcis (obtained yearly), were analyzed, with an analysis of
covariance model used to assess treatment effect for
parameters of interest.
RESULTS
• MRI assessment of trabecular microarchitecture at

individual regions of the distal radius revealed significant
improvement, or preservation (no significant loss), in the
CT-NS-treated group compared with significant
deterioration in the placebo control group, as reflected in
apparent BV/TV (p < 0.03), apparent trabecular number (p
< 0.01), and apparent trabecular spacing (p < 0.01).
• Also, at the hip, the CT-NS group exhibited preservation of
trabecular microarchitecture at the lower trochanter (p <
0.05) as determined by T2* MRI technology.
• Significant deterioration of trabecular bone architecture
was noted in the placebo group at the femoral neck.
CONCLUSIONS
• The results of the QUEST study suggest therapeutic benefit of CT-NS

compared with placebo in maintaining trabecular microarchitecture at
multiple skeletal sites.
PROOF STUDY
• 5-year, double-blind, randomized, placebo-controlled

study to determine whether salmon calcitonin nasal spray
reduced the risk of new vertebral fractures in
postmenopausal women with osteoporosis
• 1,255 postmenopausal women with established
osteoporosis were randomly assigned to receive salmon
calcitonin nasal spray (100, 200, or 400 IU) or placebo
daily.
• All participants received elemental calcium (1,000 mg)
and vitamin D (400 IU) daily.
• Vertebral fractures were assessed with lateral radiographs
of the spine
RESULTS
• A total of 783 women completed 3 years of treatment,

and 511 completed 5 years.
• The 200-IU dose of salmon calcitonin nasal spray
significantly reduced the risk of new vertebral
fractures by 33% compared with placebo .
• The reductions in vertebral fractures in the 100-IU
and the 400-IU groups were not significantly
different from placebo.
CALCISPRAY AND BONE PAIN
• The analgesic effect of nasal salmon calcitonin was evaluated in in

patients with acute pain due to recent, nontraumatic osteoporotic
vertebral crush fractures.
• 32 men and 68 postmenopausal women were studied using a
prospective, double-blind, placebo-controlled clinical design.
RESULTS
• Men and women taking 200 IU of nasal salmon

calcitonin daily for a period of 28 days had a
dramatic decrease of spinal pain.
• This analgesic effect was accompanied by early
mobilization and gradual restoration of the
locomotor functions, such as sitting, standing and
walking.
• Patients receiving the placebo nasal spray
remained in bed for almost the entire period of
observation.
CALCISPRAY AND BONE PAIN
• The analgesic effect of nasal salmon calcitonin was evaluated in in

patients with acute pain due to recent, nontraumatic osteoporotic
vertebral crush fractures.
• 32 men and 68 postmenopausal women were studied using a
prospective, double-blind, placebo-controlled clinical design.
Acta Orthop Scand Suppl. 1997 Oct;275:112-4.
RESULTS
• Men and women taking 200 IU of nasal salmon

calcitonin daily for a period of 28 days had a
dramatic decrease of spinal pain.
• This analgesic effect was accompanied by early
mobilization and gradual restoration of the
locomotor functions, such as sitting, standing and
walking.
• Patients receiving the placebo nasal spray
remained in bed for almost the entire period of
observation.
ANALGESIC EFFECT OF INTRANASAL
SALMON CALCITONIN IN THE TREATMENT
OF OSTEOPOROTIC VERTEBRAL
FRACTURES.
• The analgesic effect of salmon calcitonin, administered intranasally

(200 IU per day), was assessed in 18 patients with acute collapse of
one to four vertebrae.
• Pain was evaluated by a descriptive pain scale as well as by the daily
consumption of analgesic drugs.
RESULTS
• When compared with placebo, intranasal salmon calcitonin

significantly relieved pain and occasioned a decrease in the
consumption of analgesic drugs.
• No major side effects were reported by the patients under study.
CLINICAL OUTCOME OF SALMON
CALCITONIN NASAL SPRAY TREATMENT
IN POSTMENOPAUSAL WOMEN AFTER
TOTAL HIP ARTHROPLASTY.
• In an open study, 37 women who had undergone

cementless THA after accidental hip fractures were
treated twice daily with 200 IU of salmon calcitonin
nasal spray for 12 months.
• A parallel group of 38 women with a similar clinical
status in terms of hip fractures and cementless THA
were treated with 1,000 mg calcium plus 880 IU
vitamin D daily through the treatment period.
RESULTS
• The results of this 12-month clinical trial show

that 200 IU of salmon calcitonin nasal spray per
day significantly improves the clinical outcome of
postmenopausal elderly women following THA.
• Treatment with a salmon calcitonin nasal spray
significantly reduces bone turnover, loss of bone
density, and pain.
• The functional status of the patients was
improved and the risk of falling reduced by
rehabilitation during the observation period of 12
months.
Treasure your bones !

Management of Osteoporosis and Bone Pain Calcitonin Nasal Spray-Calcispray

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Management of Osteoporosis and Bone pain

CALCITONIN NASAL SPRAY-CALCISPRAY

• Calcitonin is a polypeptide hormone secreted by the

40- 50 times more potent than

• Ease of drug administration, Sp for older Pts

• Calcitonin decrease in the rate of bone resorption.

• Bone pain is a symptom frequently associated with bone disease

• The analgesic effect can be evident as soon as the second week of

• Calcitonin and morphineinduced analgesia, and reports of calcitonin-

• However, the demonstration of calcitonin binding sites in areas of the

• Osteoporosis : The recommended dosage of

• Bone pain associated with osteolysis and/or

• Hypersensitivity to synthetic calcitonin (salmon) or to any of the

• It should be administered as 1 spray per day into a nostril, alternating

Salmon calcitonin may cause allergic reactions, runny nose, bleeding

• No instances of overdose with calcitonin-salmon

• Ninety-one postmenopausal osteoporotic women were

• MRI assessment of trabecular microarchitecture at

• The results of the QUEST study suggest therapeutic benefit of CT-NS

• 5-year, double-blind, randomized, placebo-controlled

• A total of 783 women completed 3 years of treatment,

• The analgesic effect of nasal salmon calcitonin was evaluated in in

• Men and women taking 200 IU of nasal salmon

• The analgesic effect of nasal salmon calcitonin was evaluated in in

• Men and women taking 200 IU of nasal salmon

• The analgesic effect of salmon calcitonin, administered intranasally

• When compared with placebo, intranasal salmon calcitonin

• In an open study, 37 women who had undergone

• The results of this 12-month clinical trial show

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