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FREEDOM extension: Denosumab reduced fractures in postmenopausal women

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HOUSTON — Denosumab was well-tolerated among postmenopausal women with osteoporosis while significantly increasing bone mineral density and reducing fracture incidence, researchers determined during a 3-year extension of the ongoing FREEDOM trial.

Based on the latest FDA prescribing information, denosumab (Prolia, Xgeva; Amgen Inc.) was initially approved in the US market in 2010. Both are labeled RANK ligand (RANKL) inhibitors.

Prolia is indicated for the treatment of postmenopausal women with osteoporosis with high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Denosumab is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Henry G. Bone, MD, director of the Michigan Bone and Mineral Clinic, head of endocrinology at St. John Hospital and Medical Center in Detroit, and adjunct professor at the University of Michigan, and colleagues aimed to evaluate denosumab’s efficacy and long-term safety in the FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial.

“Its long-term treatment was generally well-tolerated, maintained bone turnover in a reduced range and continued to increase the bone density, with low fracture incidence,” Bone said during a presentation.

Of the 5,928 women eligible to participate in the FREEDOM extension, 4,550 (77%) enrolled in the Amgen-sponsored trial (n=2,207 cross-over; n=2,343 long-term). Patients were administered 60 mg denosumab every 6 months plus calcium and vitamin D supplements daily.

Results from the intention-to-treat analysis pre-specified per protocol and modified per protocol subsets represented a total of 6 years of denosumab exposure.

The cross-over group had gains in BMD at the lumbar spine and total hip during the first 3 years of the extension. Additional increases took place over years 4 to 6 in the long-term group, Bone said.

Denosumab was found to reduce the risk for new vertebral fractures (2.3% denosumab vs. 7.2% placebo) and novertebral fractures (6.5% denosumab vs. 8% placebo) over 3 years.

Bone said overall adverse events, including serious events, did not increase in patients who took denosumab over time, nor did these patients develop neutralizing antibodies to the drug. The extension trial is ongoing. – by Samantha Costa

For more information:

Bone HG. Abstract #S18-2. Presented at: the Endocrine Society’s 94th Annual Meeting & Expo. June 23-26, 2012; Houston.

Disclosure: Drs. Henry G. Bone, Jacques P. Brown, Roland Chapurlat, Nathalie Franchimont, Edward Czerwinski, Sebastiao C. Radominski, Jean Yves Reginster, Nadia S. Daizadeh, Andrea Wang, Michelle L. Geller, Rachel B. Wagman, and Scorates Papapoulos report several disclosures with numerous pharmaceutical and medical entities. All other researchers report no relevant financial disclosures.