Comparison of Efficacy and Safety of Denosumab with Eldecalcitol or Native Vitamin D in Postmenopausal Chinese Women with Osteoporosis (ESCORT): A Randomized Controlled Trial
Abstract
Background: Eldecalcitol (ELD) and denosumab are some of the most common therapeutic options for osteoporosis management. ELD effectively increases bone mineral density (BMD) in osteoporotic patients, independent of baseline vitamin D status or calcium intake. However, the efficacy of denosumab combined with either ELD or native vitamin D plus calcium in postmenopausal Chinese women with osteoporosis has not been established. Methods: In this single-center, randomized, open-label, active-controlled clinical trial, postmenopausal women with osteoporosis (defined as a BMD T-score ≤ -2.5 at the lumbar spine [LS], total hip [TH], or femoral neck [FN], or low bone mass with fragility fracture history) were enrolled from Xi'an Honghui Hospital in China and randomized 1:1 to two 12-month treatment regimens: the ELD group received ELD (0.75 μg orally daily) combined with denosumab (60 mg subcutaneously every 6 months), while the control group received the same denosumab regimen plus native vitamin D (800 IU orally daily) and calcium (600 mg orally daily). The primary endpoint was the 12-month percent change in LS BMD from baseline. Secondary endpoints included changes in FN- and TH-BMD from baseline, bone turnover markers, serum parathyroid hormone, quality of life, and the incidence of new fractures. Results: Of the 100 randomized participants, 45 in the ELD group and 46 in the control group were included in the efficacy analysis. After 12 months of treatment, LS-BMD increased…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
Read the paper
Related studies
- Effectiveness of Bisphosphonates and Denosumab on Risk of Vertebral Fractures in Prostate Cancer Patients Under Androgen Deprivation Therapies: A Real-World Prospective Study
- Osteoporosis-related fractures after spinal cord injury: a retrospective study from Brazil
- Serum 25-hydroxyvitamin D, parathyroid hormone, and mortality in older men
- Lack of Association between Vitamin D Insufficiency and Cardiovascular or Fracture Risk: A UK Biobank Study
- Muscle strength and body composition are clinical indicators of osteoporosis
- Incidence of bone protection and associated fragility injuries in patients with proximal femur fractures
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.