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Forteo reduces nonvertebral fractures, increases BMD in type 2 diabetes, osteoporosis
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Adults with type 2 diabetes and osteoporosis prescribed Forteo therapy saw a lower incidence of vertebral fractures over time, increased bone mineral density and reduced back pain, according to a post hoc analysis of the DANCE trial.
“In this observational study, [Forteo (teriparatide, Eli Lilly)] reduced incidence of nonvertebral fracture over time, and there was no evidence that the effects differed by diabetes status,” Ann V. Schwartz, PhD, professor in the department of epidemiology and biostatistics at University of California, San Francisco, and colleagues wrote. “Patients with type 2 diabetes showed similar BMD increases at the spine and total hip compared with patients without diabetes, and showed greater increase in BMD at the femoral neck compared with patients without diabetes.”
Schwartz and colleagues analyzed data from 4,042 adults with osteoporosis at high risk for fracture participating in the Direct Analysis of Nonvertebral Fractures in the Community Experience (DANCE), an open-label, prospective, multicenter observational study. Within the cohort, 291 patients had type 2 diabetes (mean age, 69 years). Analysis included patients receiving at least one dose of teriparatide (20 µg/day subcutaneously); diagnostic imaging was performed at the discretion of the investigators; BMD was assessed by DXA.
Primary outcome was the occurrence of nonvertebral fractures in patients treated with teriparatide for up to 24 months in a community-based setting; secondary outcomes included assessments of BMD, back pain and serious adverse events.
At 1 year, 2,546 patients remained on teriparatide treatment (171 with type 2 diabetes); 2,099 patients completed the study (133 with type 2 diabetes); 74 patients with type 2 diabetes completed 2 years of teriparatide therapy.
In a Kaplan-Meier analysis of diabetic vs. non-diabetic groups, researchers found no between-group difference in time to new nonvertebral fracture (HR = 1.06; 95% CI, 0.49-2.3). Cox proportional hazards models showed similar results, as did an analysis of “all observation” (combined treatment and cessation periods). Fracture incidence was 3.5 per 100 patient-years during months 0 to 6 for patients with type 2 diabetes vs. 3.2 per 100 patient-years for those without diabetes. From 6 months to treatment end, fracture incidence was 1.6 per 100 patient-years for those with type 2 diabetes vs. 1.8 per 100 patient-years for those without diabetes.
Patients with and without type 2 diabetes showed similar increases in BMD at 18 months at the lumbar spine and total hip; patients with type 2 diabetes showed a greater increase in femoral neck BMD vs. patients without diabetes (0.034 g/cm² vs. 0.004 g/cm²). Both groups experienced a decrease from baseline in mean back pain scores that continued through the end of treatment. There were no new safety findings.
The researchers noted that only 44% of patients with type 2 diabetes were prescribed another osteoporosis medication during the cessation period vs. 56.3% of patients without type 2 diabetes (P = .0007).
“Since antiresorptive therapy after teriparatide may help maintain and further increase BMD and potentially prolong a lower incidence of nonvertebral fractures, patients with diabetes and osteoporosis should be considered for follow-up osteoporosis treatment after completing a course of teriparatide,” the researcher wrote. “These findings suggest that the skeletal management of patients with type 2 diabetes may require greater clinical attention.” – by Regina Schaffer
Disclosure: The study was funded by Eli Lilly and Co. Schwartz reports receiving speakers’ honorarium from Chungai Pharmaceutical Co. and serving on an advisory board for Janssen. Please see the full study for the other authors’ relevant financial disclosures.
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