Bone

Risedronatın kalçanın yapısal geometrisi üzerine etkisi: Kemoterapi ile indüklenmiş menopoz sonrası kadınlarda yapılan bir yıl süreli çift-kör bir klinik çalışma
G.J. van Londena *, S. Pererab, K.T. Vujevicha, S.M. Sereikac, R. Bhattacharyad, S.L. Greenspana
aMedicine, University of Pittsburgh, Pittsburgh, PA, USA
bMedicine and Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA
cBiostatistics, Health and Community Systems, and Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA
dMedicine, University of Kansas, Kansas City, KS, USA
Article Language: TR
ÖZET
 Giriş: Kemoterapi ile indüklenmiş menopoz kemik kaybı ile ilişkilidir. Yapısal geometri üzerine etkisi ise bilinmemektedir. Bu çalışmanın amacı, kemoterapi ile menopoz oluşturulan meme kanserli hastalarda oral bifosfonat tedavisinin normal femur geometrisinin sürdürülmesi ya da iyileştirilmesi üzerine etkili olup olmadığının araştırılmasıdır. Metotlar: Meme Kanserinde Görülen Kemik Kaybına Risedronatın Etkisi Çalışması (REBBeCA)'nda önceden planlanmış olan bu bir yıllık çift-kör sekonder ara analizde, yeni menopoz oluşturulmuş, metastazı olmayan 87 meme kanserli hasta randomize şekilde haftada bir kez 35 mg risedronat ve plasebo gruplarına ayrılarak, kemik kesitsel alanındaki değişimleri, kesit modülünü (eğilme dayancının ölçüsü), kortikal kalınlığı ve burkulma oranını (kortikal kemik stabilite indeksi) da içine alacak şe-kilde kalça yapısı analizleri yapılmıştır. Bulgular: On iki ay sonra yapılan ölçümlerde, risedronat grubu ile plasebo grupları karşılaştırıldığında, intertrokanterik parametrelerin yüzdelerinde bazale göre iyileşme olduğu gözlendi: kemik kesitsel alanındaki değişim (ortalama ± standart sapma) risedronat grubunda %4.25 ± 6.29, plasebo grubunda %0.60 ± 5.99, kesit modülündeki yüzde değişim risedronat grubunda %3.97 ± 6.40, plasebo grubunda %0.80 ± 7.08, kortikal kalınlıktaki değişim risedronat grubunda %5.20 ± 6.98, plasebo grubunda %1.13 ± 6.87 olarak saptandı. Tüm karşılaştırmalar için p değeri 0.05'ten düşük olup, yalnızca kesit modülündeki yüzde değişimler için p değeri 0.0643 olarak hesaplandı. Benzer iyileşmeler femur cisminde de gözlendi [kemik kesitsel alanı: risedronat grubunda %2.24±5.74 ve plasebo grubunda %−0.78 ± 5.73; kesit modülü: risedronat grubunda %1.62 ± 6.23 ve plasebo grubunda %−1.39 ± 7.06; kortikal kalınlık: risedronat grubunda %3.79 ± 7.84 ve plasebo grubunda %−0.17 ± 7.90 (tüm karşılaştırmalar için p değeri 0.05'ten düşük olup, yalnızca kesit modülündeki yüzde değişimler için p değeri 0.0568). Her iki kısımda da güç artışı ile bağlantılı olarak burkulma oranlarında anlamlı düşüş olduğu gözlendi. Sonuç: Meme kanserli kadınlarda kemoterapi sonrası verilen risedronatın kalçanın yapısal geometrisine ilişkin ölçümlerde iyileşme oluşturduğu sonucuna varıldı.

Anahtar Kelimeler: Meme kanseri; Kemoterapi; Osteoporoz; Risedronat; Kalça yapısının analizi
ABSTRACT
 Introduction: Chemotherapy-induced menopause is associated with bone loss. The effect on structural geometry is unknown. Our objective was to determine if oral bisphosphonate therapy could maintain or improve femoral geometry in breast cancer patients with chemo- therapy-induced menopause. Methods: This preplanned 1 year interim, secondary analysis of the Risedronates Effect on Bone loss in Breast CAncer Study (REBBeCA Study) examined hip structure analysis (HSA), i.e. changes in the bone cross-sectional area (bone CSA), section modulus (SM: measure of bending strength), cortical thickness (CT) and buckling ratio (BR: index of cortical bone stability), in a double-blind trial of 87 newly postmenopausal, nonmetastatic breast cancer patients, randomized to risedronate, 35 mg once weekly (RIS) versus placebo (PBO). Results: After 12 months, intertrochanteric parameters demonstrated percentage improvement (RIS vs. PBO) frombaseline in bone CSA (mean±SD: 4.25±6.29 vs. 0.60±5.99%), SM(3.97±6.40 vs. 0.80±7.08%), and CT [5.20±6.98 vs. 1.13±6.87% (all p-values <0.05 except SM p=0,0643)]. Similar improvements were observed at the femoral shaft [bone CSA: 2.24±5.74 vs. −0.78±5.73%; SM: 1.62±6.23 vs. −1.39±7.06%; CT: 3.79±7.84 vs. −0.17±7.90% (all p-values <0.05, RIS vs. PBO, except SM p= p =0.0568)]. At both sites, the BR had significant decreases consistent with improved strength. Conclusion: We conclude that RIS improves measures of hip structural geometry in women with breast cancer following chemotherapy.

Keywords: Breast cancer; Chemotherapy; Osteoporosis; Risedronate; Hip structural analysis

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