Denosumab effective Osteoporosis drug. On February 18, 2009 Amgen, the company making this drug, announced that "the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for this drug. ab=n investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer."
The drug has since been approved and it is sometimes sold under the name of Prolia It is administered by injection and is taken in doses several months apart. One study of post menopausal women had some take the drug every three months while others took it at six month intervals.
It provides a real alternative for those who find oral Osteoporosis medications difficult.
1. In 2013 the International Osteoporosis journal published a study:
Effect on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial.
Summary: In a phase 2 study, continued treatment for up to 8 years was associated with continued gains in bone mineral density and persistent reductions in bone turnover markers. The treatment was well tolerated throughout the 8-year study.
2. Previous to that study the Journal of Bone Mineral Research had published: Relationship between bone mineral density changes with this treatment and risk reduction for vertebral and nonvertebral fractures in March of 2012.
This study abstract states in part: " (It) significantly increased total hip BMD by 3.2%, 4.4%, and 5.0% at 12, 24, and 36 months, respectively. Denosumab decreased the risk of new vertebral fractures by 68% (p < 0.0001) and nonvertebral fracture by 20% (p = 0.01) over 36 months. Regardless of the method used, the change in total hip BMD explained a considerable proportion of the effect . . . in reducing new or worsening vertebral fracture risk (35% [95% confidence interval (CI): 20%–61%] and 51% [95% CI: 39%–66%] accounted for by percent change at month 36 and change in time-dependent BMD, respectively) and explained a considerable amount of the reduction in nonvertebral fracture risk (87% [95% CI: 35% – >100%] and 72% [95% CI: 24% – >100%], respectively)."
2. An important study was published in 2014 that showed this drug is associated with A-typical femoral fractures. You can read the full articles at Denosumab and A-typical fractures
Read about other Osteopenia and Osteoporosis medications
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