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.