• DOI:10.1210/jc.2012-1569
• Corpus ID: 23812781

A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density.

@article{Orwoll2012ARP,
  title={A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density.},
  author={Eric S. Orwoll and Christence Stubbe Teglbj{\ae}rg and Bente Lomholt Langdahl and Roland D. Chapurlat and Edward Czerwiński and David Kendler and Jean-Yves Reginster and Alan Kivitz and E. Michael Lewiecki and Paul D. Miller and M A Bolognese and Michael R. McClung and Henry G. Bone and {\"O}sten Ljunggren and Bo Abrahamsen and Ugis Gruntmanis and Yu-Ching Yang and Rachel B. Wagman and Suresh R Siddhanti and Andreas Grauer and Jesse W Hall and Steven Boonen},
  journal={The Journal of clinical endocrinology and metabolism},
  year={2012},
  volume={97 9},
  pages={
          3161-9
        }
}

• E. Orwoll, C. S. Teglbjærg, +19 authors S. Boonen
• Published 21 June 2012
• Medicine
• The Journal of clinical endocrinology and metabolism

CONTEXT
Men with low bone mineral density (BMD) were treated with denosumab.

OBJECTIVE
Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment.

DESIGN, SUBJECTS, AND INTERVENTION
This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD.

MAIN OUTCOME MEASURE
The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12.

RESULTS
Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P ≤ 0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P < 0.0001). The incidence of adverse events was similar between groups.

CONCLUSIONS
One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed.