• Diabetes & Endocrinology Clinical Trials
• Metabolic Bone Disease
• Menopause

Henry G. Bone, MD, Michigan Bone and Mineral Clinic, Grosse Pointe, Michigan, USA, presented findings on the efficacy and safety of a shift from alendronate (ALN) to denosumab (DMAb) in a subset of women from the 1-year Study of Transitioning from Alendronate to Denosumab (STAND; NCT00377819) trial who transitioned to DMAb after 5 or more years of continuous ALN therapy.

STAND was a multicenter, international, randomized, double-blind, double-dummy study in 504 postmenopausal women aged ≥55 years with a bone mineral density (BMD) score of ≤–2.0 and ≥–4.0 or more who had been receiving ALN therapy for at least 6 months. Subjects were randomly assigned to either continued weekly ALN treatment or subcutaneous denosumab 60 mg every 6 months and were followed for 12 months. The primary endpoint was noninferiority of DMAb compared with ALN [Kendler DL. J Bone Min Res 2010].

At Month 12, total hip BMD increased by 1.9% in the DMAb group versus 1.05% in the ALN group (p<0.0001). DMAb subjects also showed significantly greater BMD gains compared with ALN at the lumbar spine, femoral neck, and 1/3 radius (all p<0.0125). Median serum c-telopeptide levels were significantly decreased in the DMAb group compared with the ALN group (p<0.0001) at all time points. Adverse events (AEs) and serious AEs were balanced between groups. No clinical hypocalcemic AEs were reported [Kendler DL. J Bone Min Res 2010].

In STAND, 149 women aged 70.0 ± 7.6 years had received ALN for ≥5 years. These women were slightly older and had worse hip but not spine BMD than those who were treated with ALN for <5 years. A total of 70 women transitioned to DMAb, and 79 women remained on ALN. Transitioning to DMAb for 12 months led to further significant increases in BMD of 2.95% (lumbar spine), 1.66% (total hip), and 1.02% (femoral neck). Those who remained on ALN had smaller changes in BMD of 1.55% (lumbar spine), 0.97% (total hip), and 0.25% (femoral neck). An interaction-by-subgroup analysis showed that the greater gains in BMD in the transition-to-DMAb subgroup that was exposed to ALN for ≥5 years were consistent with overall population results. Of the women who received ALN for ≥5 years, a similar number of AEs were reported in those who transitioned to DMAb and those who continued to receive ALN (81.4% and 84.8%, respectively). The most frequently reported AEs for both groups combined were nasopharyngitis (16.1%), back pain (11.4%), nausea (7.4%), bronchitis (7.4%), pain in the extremities (7.4%), and arthralgia (7.4%). There were no cases of osteonecrosis of the jaw, delayed fracture healing, or atypical femoral fractures.

According to Dr. Bone, results from the STAND follow-up study are consistent with those from the overall STAND study—ie, that the transition to DMAb after ≥5 years of continuous ALN treatment led to further significant gains in BMD at the lumbar spine, total hip, and femoral neck—and demonstrated a similar safety profile compared with patients who continued on ALN.

• © 2011 MD Conference Express