LUNAR NEWS
LUNAR NEWS
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1b
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1e
1f
2a
Merck
Fosamax
2b
a b c
MERCK
2c
The difficulties with oral
bisphosphonates may favor their episodic once/week , or cyclical one week each monthadministration.
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3b
3c
3a
3b
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3c
3c
2a 2b 2c
2a
2b 2c
3c
episodic 2c
once/week
episodic once/week , or cyclical one week each month
administration episodic cyclical once/week one
week each month
LunarCorporation LunarCorporation
LunarCorporation
July 1996 April 1997
1a 1b 1c 1f
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:
1 BM 21,0955
2 BM 21,0955
BM 21,0955
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4e
4f
4g
dosage
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4i
a
b
a
b
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4a 4g
a b
a
b
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1a 1b 1f
BISPHOSPHONATES IN H. Fleisch
BONE DISEASE, From the laboratory to the patient 2nd Edition
The American Journal of Medicine
Charles H. Chesnut Alendronate Treatment of the Postmenopausal
Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone RemodelingThe New England Journal of
Medicine Uri A. Liberman Effect of oral alendronate on bone mineral
density and the incidence of fractures in postmenopausal osteoporosis
Lancet D. M. Black
4h
BM21,0955
2 BM21,0955
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3a 3b
BM21,0955
4c
1e
Gibbs,C.J.,Aaron,J.E.;Peacock,M.,Br.Med.J.292,pp.1227
1229 1986 1990 11
E.Sirisetal.,J.Clin.Endocrinol.Metab.,81,961-967 1996 3b
4e 4i
4g
1a 1b 1c 1f
3c
2a 2b 2c
2 3c
Calcified Tissue International M.C.de Vernejoul Different
Schedules of Administration of 3 Amino-1-Hydroxypropylidene -1, 1 BisphosphonateInduce Different Changes in Pig Bone Remodeling
2c
2c episodic once/week
episodic
once/week
once/week one week each month
may favor
2c potentially
Some U. S. physicians are reluctant to treat because of: a
side effects, b difficulty of dosing, and c high costs $700/year .
a b c $700/
This antagonism
possibly could be a factor in the unexpectedly high frequency of side effects and dosingdifficulties.
side
effects difficulty of dosing
dosing problem
difficulty of dosing side effects
4d
1a 1b 1f
3a 3b
2 BM21,0955
BM21,0955
BM21,0955
3 BM21,0955
BM21,0955
LUNAR NEWS FROM THE LEADER
IN BONE MEASUREMENT
In This Issue
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Therapy Update
Bisphosphonate
REFERENCES
LUNAR NEWS Lunar Corporation
Lunar Corporation
2 Studies over the past decade have given
physicians confidence that bisphosphonates,and in particular alendronate,are useful intreating osteoporosis. Control of alendronate administration,as in the FIT study,canminimize side effects. In the FIT study,40% of the placebo group had uppergastrointestinal problems compared to 41.3% in the alendronate-treated group.FIT
Oral bisphosphonate therapy in subjects older than 70 years is complicated bygastro-esophageal and intestinal difficulties more than in younger patients.the potential side-effects
In pigs, the bisphosphonate dose can be reduced without adverse effect
on skeletal response by giving a standard "daily dose" every fourth day, or for 5 days outof 20 23 .
3 2c episodic once/week
episodic once/week
may favor
2c
potentially
episodic once/week
once/week episodic
once/week episodic
may favor potentially 2c
2c
side effects difficulty of
dosing 2c dosing problem
difficulty of dosing side effects
Some U. S. physicians are reluctant to treat because
of: a side effects, b difficulty of dosing, and c high cost $700/year . First,Merck recently sent a letter to physicians warning of esophagitis. Some physicians reportthat 5 to 15% of patients experience gastric and/or esophogeal distress, but most have seenno side effects. Serious side-effects of ulceration and stricture appear rare 14 . Second,some patients also stop alendronate because of the dosing difficulty. The limitedbioavailability of alendronate 0.8% requires that it be taken on an empty stomach uponawakening with a full glass of water not tea, coffee, or juice , and the patient mustremain upright for 30 to 60 minutes 15 . A few elderly women can tolerate this regimefor a only week or two. a , b
c Merck
First,
Second, a side effects b
difficulty of dosing
Third,
side effects
This antagonism possibly could be a factor in the
unexpectedly high frequency of side effects and dosing difficulties.
The
difficulties with oral bisphosphonates may favor their episodic once/week , or cyclicalone week each month administration. Even oral alendronate potentially could be givenin a 40 or 80 mg dose once/week to avoid dosing problems and reduce costs.2c
2c dosing problems
Herbert Fleisch
BISPHOSPHONATES IN BONE DISEASE alendronate is very well tolerated
up to a daily oral dose of 20mg. At 40mg signs of upper gastrointestinal intolerance mayoccur. alendronate is very well tolerated at the recommended dosage.
The American Journal of Medicine
Charles H. Chesnut, Alendronate Treatment of the Postmenopausal
Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone RemodelingThe only adverse clinical or laboratory effects that appeared to be
related to alendronate were upper gastrointestinal intolerance and rash. The formerincluded nausea, dyspepsia, mild esophagitis/gastritis, and abdominal pain, and occurredprimarily in the first year during treatment with 40 mg alendronate. Seven and 2 patientsdiscontinued study participation due to adverse gastrointestinal effects in the first andsecond years, respectively. Of these 9 patients withdrawn from alendronate therapy due toan adverse upper gastrointestinal effects, 7 were receiving 40 mg and only 1 was receiving
a dose lower than 20 mg.
Therapy with
alendronate was associated with few side effects; upper gastrointestinal intolerance was themost common adverse experience,and was usually related to the 40-mg dosage. In thisstudy, alendronate treatment for 2 years improved and maintained skeletal bone mass. Theoptimal dosage, associated with minimal side effects, appears to be 5 to 10 mg. At suchdodages, alendronate therapy appeared to be well tolerated and effective for the treatmentof osteoporosis in postmenopausal women in this study.
The New England Journal of Medicine
Uri A. Liberman EFFECT OF ORAL
ALENDRONATE ON BONE MINERAL DENSITY AND THE INCIDENCE OF
FRACTURES IN POSTMENOPAUSAL OSTEOPOROSIS
Continuous therapy with 10 mg of alendronate per day provided maximal efficacy, waswell tolerated and is therefore the optimal dose for the treatment of osteoporosis inpostmenopausal women.
Today's Therapeutic Trends
Jonathan D. Adachi Osteoporosis Its
Diagnosis,Management and Treatment with a New Oral Bisphosphonate Agent,
Etidronate Efficacy of alendronate was demonstrated in a recently
reported publication. 36 In a three-year randomized, double-blind,
placebo-controlled,multicentered study, 994 subjects were treated with either placebo oralendronate 5, 10 or 20 mg/day. All were supplemented with calcium 500 mg/day.Alendronate produced increases in BMD of the lumbar spine, proximal femur, forearm andtotal body at all doses. Increases in BMD continued throughout the three years of study.As the efficacy of 10 mg/day was found to be comparable to that of 20 mg/day, while 5mg/day was less effective, 10 mg/day was determined to be the appropriate alendronatedose.
TABLE 1
BM21,0955
BM21,0955
4c
BM21,0955 3
4h
a
b
4i
BM21,0955
4d
BM21,0955
4c
BM21,095
BM21,0955
BM21,0955
BM21,0955
2 BM21,0955
3a 3b 3c
Studies over the past decade have
given physicians confidence that bisphosphonates, and in particular alendronate, are usefulin treating osteoporosis. Control of alendronate administration, as in the FIT study, canminimize side effects. In the FIT study, 40% of the placebo group had uppergastrointestinal problems compared to 41.3% in the alendronate-treated group.FIT
FIT
Oral bisphosphonate therapy in subjects older than 70 years is
complicated by gastro-esophageal and intestinal difficulties more than in younger parties.2a 2b 2c
2c
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