A multi-center, single-arm, open-label study was conducted in 28 girls with McCune-Albright Syndrome and progressive precocious puberty aged 2 to < 10 years. All patients received a 1 mg daily dose of ARIMIDEX. The trial duration was 12 months. Patients were enrolled on the basis of a diagnosis of typical (27/28) or atypical (1/27) McCune-Albright Syndrome, precocious puberty, history of vaginal bleeding, and/or advanced bone age. Patients' baseline characteristics included the following: a mean chronological age of ± years, a mean bone age of ± years, a mean growth rate of ± cm/year and a mean Tanner stage for breast of ± . Compared to pre-treatment data there were no on-treatment statistically significant reductions in the frequency of vaginal bleeding days, or in the rate of increase of bone age (defined as a ratio between the change in bone age over the change of chronological age). There were no clinically significant changes in Tanner staging , mean ovarian volume, mean uterine volume and mean predicted adult height. A small but statistically significant reduction of growth rate from ± cm/year to ± cm/year was observed but the absence of a control group precludes attribution of this effect to treatment or to other confounding factors such as variations in endogenous estrogen levels commonly seen in McCune-Albright Syndrome patients.
Hello Cautious Optimist! I’m emailing because I’m also a lobular carcinoma (bi lateral mastectomy Nov 2015 – stage 1). There aren’t too many ‘lobulars’ out there so I thoughts I’d reach out to you. It’s not as common (but second most common)…only about 10% of breast cancers. It’s a sneaky one which is why I’m agonized so much over not being able to tolerate the drugs. I get every side effect and then some. I’ll just have to take my chances on the cancer I guess, but I have constant second thoughts.
Although there was a non-significant reduction in the number of hip fractures (9 on Tamoxifen, 20 on placebo) in the Tamoxifen group, the number of wrist fractures was similar in the two treatment groups (69 on Tamoxifen, 74 on placebo). A subgroup analysis of the P-1 trial, suggests a difference in effect in bone mineral density (BMD) related to menopausal status in patients receiving Tamoxifen. In postmenopausal women there was no evidence of bone loss of the lumbar spine and hip. Conversely, Tamoxifen citrate was associated with significant bone loss of the lumbar spine and hip in premenopausal women.