The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT)

Zoledronic acid 5 mg (ZOL) annually for 3 years reduces fracture risk in postmenopausal women with osteoporosis. To investigate long-term effects of ZOL on bone mineral density (BMD) and fracture risk, the Health Outcomes and Reduced Incidence with Zoledronic acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT) was extended to 6 years. In this international, multicenter, double-blind, placebo-controlled extension trial, 1233 postmenopausal women who received ZOL for 3 years in the core study were randomized to 3 additional years of ZOL (Z6, n = 616) or placebo (Z3P3, n = 617). The primary endpoint was femoral neck (FN) BMD percentage change from year 3 to 6 in the intent-to-treat (ITT) population. Secondary endpoints included other BMD sites, fractures, biochemical bone turnover markers, and safety. In years 3 to 6, FN-BMD remained constant in Z6 and dropped slightly in Z3P3 (between-treatment difference = 1.04%; 95% confidence interval 0.4 to 1.7; p = 0.0009) but remained above pretreatment levels. Other BMD sites showed similar differences. Biochemical markers remained constant in Z6 but rose slightly in Z3P3, remaining well below pretreatment levels in both. New morphometric vertebral fractures were lower in the Z6 (n = 14) versus Z3P3 (n = 30) group (odds ratio = 0.51; p = 0.035), whereas other fractures were not different. Significantly more Z6 patients had a transient increase in serum creatinine >0.5 mg/dL (0.65% versus 2.94% in Z3P3). Nonsignificant increases in Z6 of atrial fibrillation serious adverse events (2.0% versus 1.1% in Z3P3; p = 0.26) and stroke (3.1% versus 1.5% in Z3P3; p = 0.06) were seen. Postdose symptoms were similar in both groups. Reports of hypertension were significantly lower in Z6 versus Z3P3 (7.8% versus 15.1%, p < 0.001). Small differences in bone density and markers in those who continued versus those who stopped treatment suggest residual effects, and therefore, after 3 years of annual ZOL, many patients may discontinue therapy up to 3 years. However, vertebral fracture reductions suggest that those at high fracture risk, particularly vertebral fracture, may benefit by continued treatment.

"Progressiver Islam" im ausgehenden Zarenreich: Das Plädoyer des St. Petersburger Imams und Regierungsbeamten Ataulla Bajazitov (1846-1911) für die Partizipation der Muslime an der modernen Zivilisation

Ataulla Bajazitov (1846-1911) fulfilled a social double role by serving his Tatar community in St. Petersburg as imam and the Russian state as military Muslim ‘cleric’, translator and teacher. By founding Russia’s first monolingual Tatar newspaper, initiating St. Petersburg’s first Friday mosque and presenting scriptural and rational arguments for the compatibility of Islam and the modern Civilization to a Russian-speaking public as early as 1883, he has been a pioneer among the Muslims in Russia in several respects. In contrast though to similar activities of his Russian contemporary, the Krim Tatar Ismail Gasprinskii (1851-1914), Bajazitov’s endeavours have remained almost unnoticed in Western scholarship. Also in Tatarstan, his books have been only recently reprinted. The present study analyzes Bajazitov’s three monographs written in Russian, namely A Response to Ernest Renan’s lecture “Islam and Science” (1883), The Relationship of Islam towards Science and People of Different Faith (1887) and Islam and Progress (1898). There, he exposes many positions that around that time started to become key arguments of Muslim reformers in the Near East for the progressivness of Islam. The study takes also into account reactions to Bajazitov’s monographs by Russian officers in Tashkent who tried to demonstrate the backwardness of Islam, especially Nikolai Petrovič Ostroumov’s (1846-1930) response in his book entitled Quran and Progress – On the intellectual awakening of today’s Russian Muslims (1901/1903).