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Osteoporosis treatment with zoledronic acid in pediatric population at a university hospital in Western Saudi Arabia. A 13-year experience. Abdulmoein E.
Osteoporosis treatment with zoledronic acid in pediatric population at a university hospital in Western Saudi Arabia A 13-year experience Abdulmoein E. Al-Agha, FRCPCH, Rahaf S. Hayatalhazmi, MBBS.

ABSTRACT

‫ سنة باستخدام‬13 ‫ لتسليط الضوء على جتربتنا خالل‬:‫األهداف‬ ‫عالج حمض زوليدرونيك عند األطفال واملراهقني املصابني بهشاشة‬ ‫ إلثبات الفائدة‬،‫العظام االبتدائي والثانوي وعلى وجه اخلصوص‬ ‫السريرية والفعالية والسالمة مبا في ذلك النتائج الوظيفية والتي‬ .‫تتجاوز كثافة معادن العظام‬ ‫ األطفال واملراهقني‬131 ‫ وتشمل‬،‫ دراسة وصفية بأثر رجعي‬:‫الطريقة‬ ‫الذين يزورون عيادة الغدد الصماء لدى األطفال في مستشفى جامعة‬ ‫ اململكة العربية السعودية خالل الفترة من‬،‫ جدة‬،‫امللك عبد العزيز‬ ‫ وقد مت تسجيل جميع اخلصائص‬.‫م‬2015 ‫م إلى يناير‬2002 ‫يناير‬ ‫ درسنا‬.‫ مت تقييم األعراض اجلانبية‬.‫السريرية واملخبرية لكل مريض‬ ‫ مصابني بهشاشة العظام االبتدائي‬1 ‫ مجموعة‬،‫مجموعتني من املرضى‬ .‫ بهشاشة العظام الثانوي‬2 ‫واملجموعة‬ ‫ كان هناك انخفاض‬.‫ سنة‬11.43 ‫ كان متوسط عمر املرضى‬:‫النتائج‬ .‫كبير في عدد من الكسور بعد العالج بحمض الزوليدرونيك‬ 2 ‫ وفي املجموعة‬،)p=0.000( ‫ كان‬1 ‫عدد الكسور في املجموعة‬ ‫ وكان هناك انخفاض كبير في مستوى كال من‬.)p=0.005( ‫كان‬ )p=0.003( ‫) والسي تي اكس في الدم‬p=0.001( ‫األوستيوكالسني‬ ‫ و أيض ًا في مستوى األوستيوكالسني‬،1 ‫لدى املرضى في املجموعة‬ 2 ‫) في املجموعة‬p=0.008( ‫) والسي تي اكس في الدم‬p=0.003( .‫بعد املعاجلة‬ ‫ إن استخدام حمض زوليدرونيك لدى األطفال واملراهقني‬:‫اخلامتة‬ ‫ مبا في‬،‫يبدو أن له آثار إيجابية على نسبة الكسور ونوعية احلياة‬ ‫ حمض زوليدرونيك‬.‫ في أعراض األفراد‬،‫ذلك األلم والتنقل‬ ‫الوريدي يعادل غيره من منتجات البايفوسفونيت في فعاليته وسالمة‬ ‫استخدامه وهو عالج فعال وآمن مع عدم وجود مضاعفات موثقة‬ .‫ لذلك فإننا ننصح باستخدامه لألطفال‬،‫على املدى الطويل‬ Objectives: To highlight the clinical benefit, efficacy, and safety of zoledronic acid (ZA) therapy in children and adolescents with primary and secondary osteoporosis. Methods: This is a retrospective observational study of 131 children and adolescents visiting the Pediatric

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Saudi Med J 2015; Vol. 36 (11)

www.smj.org.sa

Endocrine Clinic at King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia, between January 2002 and January 2015. Clinical and laboratory data were collected for each patient and adverse events were evaluated. Results: The mean patient age was 11.43 years. There was a significant decrease in the number of fractures after ZA treatment for primary osteoporosis (p=0.000) and in secondary osteoporosis (p=0.005). There was a significant decrease in both osteocalcin (p=0.001) and C-terminal telopeptide (p=0.003) in patients with primary osteoporosis, as well as osteocalcin (p=0.003) and C-terminal telopeptide (p=0.008) in patients with secondary osteoporosis after treatment. Conclusion: The use of ZA in children and adolescent appears to have favorable effects on fracture rate and quality of life, including pain and mobility in symptomatic individuals. Intravenous ZA is comparable to other bisphosphonate agents in its efficacy and safety and features a more convenient infusion protocol with no documented long-term complications, thus, we advise its use in pediatric population. Saudi Med J 2015; Vol. 36 (11): 1312-1318 doi: 10.15537/smj.2015.11.12590 From the Department of Pediatrics (Al-Agha), Faculty of Medicine, King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia, and Department of Family Medicine (Hayatalhazmi), Faculty of Health, Maastricht University, Maastricht, Netherlands. Received 11th June 2015. Accepted 22nd September 2015. Address correspondence and reprint request to: Dr. Abdulmoein E. Al-Agha, Department of Pediatrics, Faculty of Medicine, King Abdulaziz University Hospital, PO Box 80215, Jeddah 21589, Kingdom of Saudi Arabia. E-mail: [email protected]

Disclosure. Authors have no conflict of interest, and the work was not supported or funded by any drug company.

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Osteoporosis in children ... Al-Agha & Hayatalhazmi

O

nce a concern exclusively in the elderly, osteoporosis is becoming a major concern among the global pediatric population.1 Despite being the most common human metabolic disorder in adults, its prevalence in the pediatric population is not well identified. Osteoporosis is generally characterized by a decrease in bone mass and density that can lead to an increased fracture susceptibility. As childhood and adolescence are critical periods for skeletal maturity, as well as bone growth and strength, osteoporosis can hamper those parameters in various ways. Therefore, teenagers should be targeted as an at-risk population, and preventive measures should be implemented to maximize bone mass, and theoretically decrease lifelong fracture risk. Causes of childhood osteoporosis are classified into primary; those that are due to an intrinsic bone abnormality (usually genetic in origin), and secondary; those that are due to underlying medical conditions, or their treatment. Both primary and secondary osteoporosis have been observed and considered in this study population. Bisphosphonates are pyrophosphate analogs that increase bone mineral density (BMD) by inhibiting bone resorption, which favors bone formation during remodeling.2,3 They are currently the main pharmacological agents for the management of childhood osteoporosis.4 Zoledronic acid (ZA; Zometa Inc., Novartis Pharma AG, Lichtstrasse, Switzerland) is a new-generation heterocyclic nitrogen-containing bisphosphonate that has demonstrated markedly higher potency, and a greater therapeutic ratio in clinical trials than earlier generation bisphosphonates, including pamidronate.5,6 Up to date, many studies have investigated bisphosphonate treatment primarily with the use of pamidronate in many bone related diseases.7 As to the ZA treatment of pediatric osteoporosis, there are no published data on long-term use, safety and efficacy. Moreover, there are no Saudi local, Arabian, or even internationally published data on a large study number of children receiving ZA. In this study, we aim to review a 13-year experience with primary and secondary causes of osteoporosis, as well as the efficacy, and safety of intravenous ZA as the treatment of choice in our pediatric population at the King Abdulaziz University Hospital (KAUH), Jeddah, Kingdom of Saudi Arabia (KSA). Methods. This retrospective observational study examined children and adolescents with primary and secondary osteoporosis followed up at the Pediatric Endocrine Outpatient Clinic at KAUH, Jeddah, KSA between January 2002 and January 2015. A total of 131 patients aged 6 weeks to 18 years were included in the

study. Data were obtained from a direct interview of patients and/or their parents, and all laboratory results were obtained from the KAUH electronic Phoenix system. These data comprised clinicodemographic information, anthropometric measurements, and main etiological factors and treatment methods. Informed verbal consent was acquired from all patients and/ or their parents prior to the start of therapy. Patients with clinical or biochemical (high bone turnover marker, C-terminal telopeptide [CTX], and osteocalcin levels) confirmed the diagnosis of osteoporosis, and/ or a z-score ≤-2.0 SD on a bone densitometry (DXA) scan were included in the study. Moreover, patients with a normal bone profile (calcium, phosphate, and alkaline phosphatase), as well as normal total vitamin D and parathyroid hormone (PTH) levels before the start of treatment were included. Exclusion criteria included mineral metabolism disturbances, major data insufficiency, and a creatinine clearance rate