Background/Purpose: To compare the efficacy of denosumab (DEN) and oral alendronate (ALN) on spinal bone mineral density (BMD) in long-term glucocorticoid users.

Methods: Patients receiving long-term prednisolone treatment for medical illnesses were recruited.  Inclusion criteria: (1) adult patients ³18 years of age; (2) prednisolone ³2.5mg/day for ³1 year.  Exclusion criteria: (1) previous use of DEN, teriparatide; (2) plan for pregnancy; (3) metabolic bone disease or unexplained hypocalcemia; (4) renal insufficiency.  Participants were randomized to receive either: (1) DEN (60mg subcutaneously every 6 months); or (2) ALN (70mg/week).  Calcium (Caltrate 3000mg/day) and vitamin D3 (cholecalciferol 1000IU/day) was given.  BMD (femoral neck, total hip, lumbar spine) at month 0, 6 and 12 months were performed.  Markers of bone turnover (serum P1NP and CTX) were also assayed at the same time points.  The primary outcome was the difference of lumbar spine BMD change at month 12 between the two groups.

Results: 139 subjects were recruited (age 50.0±12.7 years): 69 assigned DEN and 70 assigned ALN.  Underlying medical diseases: SLE (81%), RA (9.4%) and myositis (5%).  Prednisolone dose at entry was 5.7±2.1mg/day.  56% of female patients were postmenopausal.  73(53%) of patients were osteoporotic (T score < -2.5) at the hip, femoral neck or lumbar spine.  The mean body mass index (BMI) was 23.1±4.1kg/m² (11% patients had BMI< 18kg/m²).  82(59%) patients were naive to bisphosphonates.  Pre-existing fragility or vertebral fracture was present in 19 (14%) patients and 18 patients (13%) had a family history of fractures.  Baseline demographic data, osteoporotic risk factors, and BMD at various sites were not significantly different between the two groups at entry.  At month 12, a significant gain in BMD at the lumbar spine (+3.5±2.5%; p< 0.001) and the hip (+0.9±2.8%; p=0.01) was observed in DEN-treated patients, whereas the corresponding change was +2.5±2.9% (p< 0.001) and +1.6±2.7% (p< 0.001) in the ALN group.  The spinal BMD at month 12 was significantly higher in the DEN than ALN group after adjustment for BMD values at baseline, age, sex and other osteoporosis risk factors that included smoking, drinking, cumulative steroid doses in one year, BMI, menopausal status and personal history of fracture (p=0.045).  The differences in hip and femoral neck BMD were not significantly different between the two groups after adjustment for the same confounding factors.  No new symptomatic fractures occurred in any participants at month 12.  Adverse events were similar in frequency between the two treatment arms.  Major infective episodes were uncommon (0.06/patient/year) and similar in the two groups.  Minor upper gastrointestinal symptoms and non-specific dizziness were numerically more common in the ALN but arthralgia, minor infections (eg. upper respiratory tract) and new hypertension was more commonly reported in the DEN group.  Three patients from ALN and 2 patients from DEN group were withdrawn from the study because of non-compliance but none withdrew because of adverse events.

Conclusion: In patients receiving long-term glucocorticoids, DEN is superior to ALN in raising the spinal BMD after 12 months’ treatment.  Both DEN and ALN were well tolerated.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/denosumab-versus-oral-bisphosphonate-for-osteoporosis-in-long-term-glucocorticoid-users-a-12-month-randomized-controlled-trial/