Abstract
The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for the treatment of postmenopausal women with osteoporosis. Participants who completed the FREEDOM trial were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fracture rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a “virtual untreated twin” cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw. Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. © 2012 American Society for Bone and Mineral Research
Highlights
Increased bone resorption after menopause leads to loss of bone mass and microstructural deterioration which significantly increase fracture risk
We report the effects of denosumab on bone turnover markers (BTMs), bone mineral density (BMD), fracture rates, and safety for the first 2 years of the extension
The extension trial enrolled women who had received denosumab or placebo in the FREEDOM trial,(3) and provides an opportunity to evaluate the long-term efficacy and safety of continued denosumab administration, and to reproduce the denosumab data observed in FREEDOM during the first 2 years of therapy
Summary
Increased bone resorption after menopause leads to loss of bone mass and microstructural deterioration which significantly increase fracture risk. 3-year, placebo-controlled FREEDOM trial,(3) administration of 60 mg denosumab subcutaneously every 6 months to postmenopausal women with osteoporosis significantly reduced bone turnover markers (BTMs), increased bone mineral density (BMD), and reduced new vertebral, hip, and nonvertebral fractures by 68%, 40%, and 20%, respectively. Characterization of the long-term efficacy and safety of denosumab is essential for clinical practice. The extension includes two populations: those who had received denosumab for 3 years during the core trial (long-term group) and those who had received placebo for 3 years during the core trial (cross-over group). We report the effects of denosumab on BTMs, BMD, fracture rates, and safety for the first 2 years of the extension
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