Denosumab increased persistence, BMD in postmenopausal patients

BALTIMORE — Patients previously treated with an oral bisphosphonate who still have a high risk for fracture may benefit from transitioning to denosumab, according to data presented at ASBMR 2013.

“We have in fact shown a more robust increase in [bone mineral density] at the end of the 1 year, based on total hip, femoral neck and lumbar spine. We also showed a larger reduction in bone turnover markers,” Jacques P. Brown, MD, of the CHU de Quebec Research Center and Laval University in Canada, told Endocrine Today.

Two multicenter, randomized, open-label, parallel-group studies included postmenopausal women aged at least 55 years who were randomly assigned to denosumab 60 mg (Prolia, Amgen) subcutaneously every 6 months (n=852) or an oral bisphosphonate (ibandronate [Boniva, Roche] or risedronate [Actonel, Warner Chilcott]) 150 mg by mouth each month for 12 months (n=851; mean age, 67 years). The mean T-scores of the patients were: –1.7 at the total hip, –2 at the femoral neck, and –2.4 at the lumbar spine.

Jacques P. Brown

The researchers conducted a combined post-hoc analysis on patients with a greater risk for fracture administered denosumab or bisphosphonate.

Patients at higher risk for fracture who were administered denosumab appeared to have a significantly greater increase in BMD compared with those assigned to an oral bisphosphonate at the total hip (2.2% vs. 0.8%), femoral neck (1.8% vs. 0.3%), and lumbar spine (3.8% vs. 1.4%), according to 12-month data.

“The important finding was that patients who appeared to be noncompliant with oral bisphosphonates improved their level of persistence when switched to denosumab,” Brown told Endocrine Today.

These findings were consistent with the overall study population (treatment-by-risk subgroup interaction P>.05), according to data. Further, adverse events and serious adverse events were similar between those assigned denosumab compared with those assigned bisphosphonates.

“There is a clear advantage to switching postmenopausal patients to a more convenient approach like a subcutaneous injection every 6 months,” Brown said. – by Samantha Costa

For more information:

Brown JP. John H. Carstens Memorial Distinguished Orals – Osteoporosis Treatment #1018. Presented at: the American Society for Bone and Mineral Research 2013 Annual Meeting; Oct. 4-7, 2013; Baltimore.

Disclosure: Brown reports financial ties with Abbott, Amgen, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, Servier, Takeda and Warner Chilcott.