Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled study.

PURPOSE: To determine the effectiveness and safety of the bisphosphonate risedronate in preventing bone loss in young women with breast cancer and early menopause induced by chemotherapy who are at major risk for the development of postmenopausal osteoporosis. PATIENTS AND METHODS: Fifty-three white women, aged 36 to 55 years, with breast cancer and artificially induced menopause were stratified according to prior tamoxifen use. Thirty-six patients received tamoxifen (20 mg/d). Within each stratum, patients were randomly assigned to receive risedronate (n = 27) or placebo (n = 26). Treatment consisted of eight cycles oral risedronate 30 mg/d or placebo daily for 2 weeks followed by 10 weeks of no drug (12 weeks per cycle). Patients were monitored for a third year without treatment. RESULTS: Main outcomes of the study were changes in lumbar spine and proximal femur (femoral neck, trochanter, and Ward's triangle) bone mineral density (BMD), and biochemical markers of bone turnover. In contrast to a significant decrease of BMD at the lumbar spine and hip in the placebo group, there was an increase in BMD in the risedronate group. On treatment withdrawal, bone loss ensued, which suggests that treatment needs to be continuous to maintain a protective effect on bone mass. At 2 years, the mean difference (+/- SEM) between groups was 2.5% +/- 1.2%, (95% confidence interval [CI], 0.2 to 4.9) at the lumbar spine (P = .041) and 2.6% +/- 1.1%, (95% CI, 0.3 to 4.8) at the femoral neck (P = .029). Similar results were observed at the hip trochanter. Results by stratum indicate a beneficial, although partial, effect of tamoxifen in reducing bone loss. Risedronate was well tolerated and showed a good safety profile, with no evidence of laboratory abnormalities. CONCLUSION: Risedronate appears to be a safe treatment that prevents both trabecular and cortical bone loss in women with menopause induced by chemotherapy for breast cancer.

Prevention of early postmenopausal bone loss with cyclical etidronate therapy (a double-blind, placebo-controlled study and 1-year follow-up)

The objective of the study was to evaluate the effects of cyclical therapy with etidronate and calcium on spinal and femoral bone loss in the early post menopausal period. Fifty-four women, 53 +/- 2.8 yr old (mean +/- SD) and 2.3 +/- 1.3 yr post menopause received oral doses of either 400 mg/day etidronate for 2 weeks followed by 500 mg/day elemental calcium for 11 weeks, or placebo for 14 days followed by calcium for 11 weeks, repeated over a total of 24 months. A statistically significant increase in spinal bone mineral density (BMD) was observed after 6 months in the etidronate group. At 2 yr, the mean treatment differences in spinal and femoral neck BMD were +2.93% (P < 0.02) and 2.02% (P < 0.03), respectively. Serum osteocalcin and urinary crossLaps/creatinine excretion were decreased significantly by etidronate. Etidronate was well tolerated with a safety profile similar to that of placebo. Thirty-seven women participated in a 1-yr open-label follow-up study. Twelve months after treatment withdrawal, spinal BMD in the former etidronate group decreased by 1.43% and serum osteocalcin and urinary crossLaps returned to pretreatment values. In conclusion, cyclical etidronate is an effective therapy for the prevention of both trabecular and cortical bone loss in the early menopause and has a good safety profile.

Bone mineral density of the hip measured with dual-energy X-ray absorptiometry in normal elderly women and in patients with hip fracture.

Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) in 133 normal females on five regions of the femoral site: neck, trochanteric, intertrochanteric, Ward's triangle, and total area of the proximal femur. One hundred and twenty-five women (56 older than 65, range 65-97, and 69 with an age range of 21-65) were also examined for spinal bone mineral density. The mean in vivo precision (CV%) of the measurements with repositioning assessed on five young and eight elderly patients was ranged from 0.7% to 1.7% but lower for Ward's triangle (CV = 2.95% and 3.87%). Between 30 and 90 years, a linear age-related bone mineral decrease was found at all sites with a similar magnitude of bone loss for the femoral neck, total or intertrochanteric regions (-33% to -39%). A greater decrease was found for the Ward's triangle region (-61%). In the subgroup of elderly women (65-97 years old), the lumbar BMD measured with an anteroposterior incidence did not decrease significantly with age, contrasting with an average 27% decrease of the BMD of the hip between 65 and 90 years of age. In addition, 31 patients suffering either from a cervical (n = 12) or pertrochanteric (n = 19) fracture were measured on their contralateral femur 15 to 30 days after the fracture event. The mean calculated BMD values were, depending on the measured area, from 14% to 21% lower than those reported for age-matched controls (z-score from -1.11 to -0.65). A fracture threshold was determined for each site from this population and the elderly controls.(ABSTRACT TRUNCATED AT 250 WORDS)