Objective | Inclusion Criteria | Exclusion Criteria | Result | Author’s Conclusion | ||
BMD | BTM | Fractures | ||||
To assess the resolution of effects of RIS therapy in postmenopausal women with osteoporosis who completed a 3-year, double-blind treatment period in which they received RIS 5 mg daily or placebo and were then followed for an additional year without RIS therapy | ・ Women at least 5 years post-menopausal enrolled in the original study. ・ Age < 85 years ・ Either ≥ 2 vertebral fractures or 1 vertebral fracture and low lumbar spine BMD (T-score ≤−2). | ・ Conditions that might interfere with evaluation of spinal bone loss ・ Received drugs known to affect bone metabolism, including calcitriol or cholecalciferol within 1 month prior to study entry | In the previous RIS group, BMD significantly decreased at the LS (−0.83%, 95% CI = −1.30 to −0.35) and FN (−1.23%, 95% CI = −1.87 to −2.19), but remained above baseline. | BTM after 1 year returned to baseline levels | Previous RIS group (1-year drug holiday) had 46% lower risk of morphometric vertebral fracture (RR = 0.54, 95% CI = 0.34 - 0.86) compared with previous PBO Nonvertebral fractures were 5.0% in previous PBO group and 4.8% in previous RIS group (NS) | Despite the apparent resolution of effect on BMD and BTM, the risk reduction of new vertebral fractures remained in the year after stopping treatment with the former RIS group. |