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Indian Pediatr 2016;53: 927 |
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Ibandronate in the
Treatment of Pediatric Osteoporosis
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* Stepan Kutilek,
#Ivana Plasilova and
$Jan Langer
From Departments of #*Pediatrics, Pardubice
Hospital, Pardubice; *Klatovy Hospital, Klatovy; and $Department
of Pediatrics, I Medical Facility, Charles University, Prague; Czech
Republic.
Email: [email protected]
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We administered oral ibandronate
(once a month) to 7 children (6 boys) with low bone mineral density and
prevalent low energy fractures. We observed a significant increase (17%)
in bone density after one year and additional 3% increase after second
year. No further fractures occurred.
Keywords: Bone mineral density, Fractures,
Ibandronate.
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Oral ibandronate is an effective agent in the
treatment of postmenopausal and male osteoporosis [1,2]. There are
scarce data regarding its use in children and adolescents [3-6].
We evaluated the effect of once-monthly oral
ibandronate on bone health in seven osteoporotic children (six boys and
one girl; age range 8-18 y). Informed consent was obtained from all
patients and/or their legal representatives prior to the treatment.
Patients had low spinal (L1-L4) bone mineral density (BMD) measured by
dual X-ray absorptiometry (DXA) (mean 0.746 g/cm 2;
mean Z-score -3.3) and/or prevalent low-energy fractures (Web
Table I). We have earlier published details of one of these
cases elsewhere [6]. The patients were not taking any other drugs that
could have influenced BMD (except Patient No.7) prior to its first
measurement or within last 3 months. None of the children suffered from
any other chronic disease or fulfilled criteria for osteogenesis
imperfecta. Three patients had primary osteoporosis and four had
secondary osteoporosis (Web Table I). Oral
ibandronate (150 mg/tablet) was administered at home by parents/legal
guardians once-a-month [1,2] . All patients were receiving oral calcium
(1000-1500 mg/day) and vitamin D (cholecalciferol, 1000-1500 IU/day).
Labo-ratory parameters (serum potassium, sodium, chloride, calcium,
phosphate, alkaline phosphatase, alanine-aminotransferase,
aspartate-aminotransferase, urea nitrogen, creatinine, parathyroid
hormone, osteocalcin, Crosslaps-CTx, and blood counts) were assessed on
baseline and then every three months within the first year of therapy,
and every six months afterwards. L1-L4 BMD was assessed by DXA (Lunar in
six children and Hologic in one) at the baseline and every 12 months of
the treatment. New fractures and adverse events were recorded in the
course of therapy.
The duration of the treatment was one year (n=2),
two years (n=3), and 3 years (n=2). After one year
there was a mean 17% increase in BMD to 0.866 g/cm 2
(0.118 SD); Z-score -2.2 (1.4 SD); P=0.0003. After second year of
treatment, the additional mean increase in BMD was non-significant (+3%)
0.920 g/cm2 (0.057 SD); Z-score
-2.1 (2.0 SD); P=0.4]. The two children who completed three years
treatment had mean additional 9% increase in BMD. The baseline values of
all laboratory parameters were within reference ranges and did not
significantly change in the course of the treatment. No new fractures
occurred. One child had transient epigastric pain and myalgia after the
first dose of ibandronate, without recurrence. None of the patients
experienced dental problems. We conclude that once-monthly oral
ibandro-nate might have significantly increased BMD, and probably
contributed to a reduction in fracture occurrence in these children with
osteoporosis. However, this is just a preliminary observation in few
patients that needs to be evaluated by well-controlled studies with
adequate sample size. Further, bisphosphonates are off-label drugs in
children, and should be used only in the context of an established
clinical program with specialist consultation [7].
References
1. Reginster JY, Adami S, Lakatos P, Greenwald M,
Stepan JJ, Silverman SL, et al. Efficacy and tolerability of
once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year
results from the MOBILE study. Ann Rheum Dis. 2006;65:654-61.
2. Orwoll ES, Binkley NC, Lewiecki EM, Gruntmanis U,
Fries MA, Dasic G. Efficacy and safety of monthly ibandronate in men
with low bone density. Bone. 2010;46:970-6
3. Cundy T, Wheadon L, King A. Treatment of
idiopathic hyperphosphatasia with intensive bisphosphonate therapy. J
Bone Miner Res. 2004;19:703-11.
4. Li M, Xia WB, Xing XP, Yu W, Hu YY, Jiang Y, et
al. Benefit of infusions with ibandronate treatment in children with
osteogenesis imperfecta. Chin Med J. 2011;124:3049-53.
5. Grenda R, Karczmarewicz E, Rubik J, Matusik H,
Płudowski P, Kiliszek M, et al. Bone mineral disease in children
after renal transplantation in steroid-free and steroid-treated
patients—a prospective study. Pediatr Transplant. 2011;15:205-13.
6. Kutilek S, Plasilova I, Nemec V. Once-monthly oral
ibandronate treatment in an adolescent with recurrent fractures and
inadequately low bone mass. J Paediatr Child Health. 2012;48:622-3.
7. Bachrach LK, Ward LM. Clinical review:
Bisphosphonate use in childhod osteoporosis. J Clin Endocrinol Metab.
2009;94:400-9.
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