Specifically, data presented at the FDA advisory committee meeting on dapagliflozin in July 2011 demonstrated an increase in fracture rate after 104 weeks in a dedicated study of patients with moderate renal impairment (eGFR 30-59mL/min/1.73m(2)) with 9.4% fractures on the 10 mg dose and 6% fractures on the 5 mg dose, versus zero fractures on placebo. In patients with normal renal function, they also noted a 2-fold increase in fractures. However, the sponsor argued that the imbalance was non-significant because of the associated small laboratory changes, possible influence of weight loss on fracture rate, minimal effects on bone mineral density (BMD) and inconsistencies between various short term and long term studies. Ultimately, the drug was not approved for other safety related reasons, but further studies dedicated to bone health were recommended. Later, Ljuggren et al reported no significant changes in bone markers or changes in DEXA at 50 weeks, but mean increases in phosphate were observed and trends towards increased CTX and procollagen type 1 N-terminal propeptide (P1NP) were also evident.