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Timely medication transitions avoid BMD loss in postmenopausal osteoporosis
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In postmenopausal women with osteoporosis who are discontinuing denosumab or teriparatide therapy, prompt antiresorptive therapy can maintain or further increase any gain in hip and spine bone mineral density under the previous treatment regimen, according to a follow-up analysis of the DATA and DATA-Switch studies.
“Physicians should avoid teriparatide or denosumab ‘drug holidays,’” Benjamin Z. Leder, MD, associate professor of medicine at Harvard Medical School, told Endocrine Today. “When these medications are stopped, a transition to alternate, antiresorptive therapy is indicated.”
Leder and colleagues analyzed data from 50 postmenopausal women aged at least 45 years at high risk for fracture (BMD T score –2.5 at the spine, hip or femoral neck; T score –2 with at least one BMD-independent risk factor or T score –1 with a history of fragility fracture) who participated in the Denosumab and Teriparatide Administration (DATA) study and its extension, DATA-switch, recruited between September 2009 and January 2011. During the DATA study, women were randomly assigned 2 years of therapy with teriparatide (Forteo, Eli Lilly; 20 µg daily), denosumab (Prolia, Amgen; 60 mg every 6 months) or both agents. At 2 years, women were switched to an additional 2 years of the alternate therapy; women assigned to both agents received denosumab alone. At the final DATA-Switch visit, women were counseled to follow-up promptly with their physician and strongly consider reinitiation of osteoporosis therapy.
In post hoc analysis, researchers asked patients who completed DATA-Switch to return for BMD measurements via DXA at least 12 months after their last study visit (mean return visit, 15.4 months). Researchers assessed the efficacy of antiresorptive therapies in maintaining BMD and the consequences of discontinuing treatment.
Within the returning cohort, 28 women received antiresorptive therapy: 10 received denosumab, 10 received oral bisphosphonates and eight received zoledronic acid. The mean interval between ending DATA-Switch and beginning antiresorptive therapy was 3.8 months. Among the 22 women who received no follow-up therapy, femoral neck, total hip and spine BMD decreased by a mean –4.2%, –4.5% and –10%, respectively. Among women who received follow-up therapies, BMD was maintained; mean changes in BMD at the femoral neck, total hip, and spine were –0.6%, –0.8% and –1.2%, respectively (P < .001 for all between-group comparisons).
Researchers also observed between-group differences in BMD among women discontinuing denosumab vs. those discontinuing teriparatide. Among untreated women, femoral neck BMD decreased more in those discontinuing denosumab (mean, –5.8%) vs. women who discontinued teriparatide (mean, –0.8%; P = .008). Total hip BMD, but not spine BMD, showed a similar pattern.
Among treated women, denosumab increased femoral neck and total hip BMD more than bisphosphonates, whereas BMD changes at the spine did not differ significantly.
“Moving forward, randomized controlled trials assessing the comparative efficacy of osteoporosis medications in consolidating BMD gains after teriparatide or denosumab treatment are needed,” Leder said. – by Regina Schaffer
For more information:
Benjamin Z. Leder, MD, can be reached at Endocrine Unit, Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114; email; bzleder@mgh.harvard.edu.
Disclosure: Leder reports receiving research funding from and consulting for Amgen and Eli Lilly.
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