The purpose of the present open-labeled, randomized, prospective study was to compare the effects of cyclical
etidronate combined with
alfacalcidol with those of cyclical
etidronate alone on lumbar bone mineral density (BMD),
bone resorption, and
back pain in postmenopausal women with
osteoporosis. Forty postmenopausal women with
osteoporosis, 60-86 years of age, without any vertebral fractures in the lumbar spine, were randomly divided into two groups with 20 patients in each group. One group was treated with cyclical
etidronate (oral
etidronate 200 mg daily for 2 weeks every 3 months) and the other was given cyclical
etidronate combined with
alfacalcidol (cyclical
etidronate plus
alfacalcidol 1 Ig daily continuously). The BMD of the lumbar spine (L1-L4) measured by dual-energy X-ray absorptiometry, urinary crosslinked N-terminal telopeptides of
type I collagen (NTX) measured by an
enzyme-linked
immunosorbent assay, and
back pain evaluated by the face scale score were assessed at baseline, 6 months, and 12 months. There were no significant differences in baseline characteristics including age, body mass index, years since menopause, lumbar BMD, urinary NTX level, and face scale score between the two treatment groups. Both treatments significantly reduced the urinary NTX level and
back pain. Cyclical
etidronate combined with
alfacalcidol significantly increased the lumbar BMD with a more significant reduction in the urinary NTX level than cyclical
etidronate alone, but cyclical
etidronate alone did not significantly increase the lumbar BMD. Alleviation of
back pain was similar in the two groups. These results suggest that cyclical
etidronate combined with
alfacalcidol appears to be more useful than cyclical
etidronate alone for increasing the lumbar BMD by more markedly suppressing
bone resorption in postmenopausal women with
osteoporosis.