Systematic review of raloxifene in postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia)

Abstract

PurposeTo systematically review the literature describing the efficacy, effectiveness, and safety of raloxifene for postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia).Materials and methodsMedline via PubMed and Embase was systematically searched using prespecified terms. Retrieved publications were screened and included if they described randomized controlled trials or observational studies of postmenopausal Japanese women with osteoporosis or osteopenia treated with raloxifene and reported one or more outcome measures (change in bone mineral density [BMD]; fracture incidence; change in bone-turnover markers, hip structural geometry, or blood–lipid profile; occurrence of adverse events; and change in quality of life or pain). Excluded publications were case studies, editorials, letters to the editor, narrative reviews, or publications from non-peer-reviewed journals; multidrug, multicountry, or multidisease studies with no drug-, country-, or disease-level analysis; or studies of participants on dialysis.ResultsOf the 292 publications retrieved, 15 publications (seven randomized controlled trials, eight observational studies) were included for review. Overall findings were statistically significant increases in BMD of the lumbar spine (nine publications), but not the hip region (eight publications), a low incidence of vertebral fracture (three publications), decreases in markers of bone turnover (eleven publications), improved hip structural geometry (two publications), improved blood–lipid profiles (five publications), a low incidence of hot flushes, leg cramps, venous thromboembolism, and stroke (12 publications), and improved quality of life and pain relief (one publication).ConclusionFindings support raloxifene for reducing vertebral fracture risk by improving BMD and reducing bone turnover in postmenopausal Japanese women with osteoporosis or osteopenia. Careful consideration of fracture risk and the risk–benefit profile of antiosteoporosis medications is required when managing patients with osteoporosis.

Raloxifene/SBE-β-CD Inclusion Complexes Formulated into Nanoparticles with Chitosan to Overcome the Absorption Barrier for Bioavailability Enhancement

“…Raloxifene (RXF) is clinically used as a selective estrogen receptor modulator for the treatment of postmenopausal osteoporosis and estrogen-dependent breast cancer [ 1 , 2 ]. The absolute bioavailability RXF has been reported to be merely 2% following oral administration [ 3 , 4 ].…”

Estrogen Receptor Modulators in Viral Infections Such as SARS−CoV−2: Therapeutic Consequences

“…These drugs are very similar with respect to their chemical structures. Both are used for the treatment of postmenopausal osteoporosis [ 94 , 95 ]. As mentioned above, both possess an inhibitory effect on virus replication in which they can interact with viral proteases ( Table 2 ).…”

Pharmacological and non-pharmacological means for prevention of fractures among elderly

“…A systemic review that included 15 studies reported a statistically significant increase in BMD of the lumbar spine, but not the hip region, a low incidence of vertebral fracture, decrease in markers of bone turnover, and improved hip structural geometry. [ 34 ] For lasofoxifene, another SERM, the randomized, double-blind, placebo-controlled study Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) clinical trial for vertebral fracture risk in postmenopausal women showed a 42% reduction compared with placebo ( P < 0.01), and 24% reductions in the absolute incidence of nonvertebral fracture. [ 35 ] In a 3-year randomized, double-blind, placebo-controlled study ( N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly ( P < 0.05) reduced the risk of new vertebral fractures by 42%, compared with placebo in postmenopausal women with osteoporosis.…”