Denosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. (ClinicalTrials.gov number, NCT00089791.)

BACKGROUNDRomosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. METHODSWe enrolled 7180 postmenopausal women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months. Secondary end points included clinical (a composite of nonvertebral and symptomatic vertebral) and nonvertebral fractures. RESULTSAt 12 months, new vertebral fractures had occurred in 16 of 3321 patients (0.5%) in the romosozumab group, as compared with 59 of 3322 (1.8%) in the placebo group (representing a 73% lower risk with romosozumab; P<0.001). Clinical fractures had occurred in 58 of 3589 patients (1.6%) in the romosozumab group, as compared with 90 of 3591 (2.5%) in the placebo group (a 36% lower risk with romosozumab; P = 0.008). Nonvertebral fractures had occurred in 56 of 3589 patients (1.6%) in the romosozumab group and in 75 of 3591 (2.1%) in the placebo group (P = 0.10). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group than in the placebo group after each group made the transition to denosumab (0.6% [21 of 3325 patients] in the romosozumab group vs. 2.5% [84 of 3327] in the placebo group, a 75% lower risk with romosozumab; P<0.001). Adverse events, including instances of hyperostosis, cardiovascular events, osteoarthritis, and cancer, appeared to be balanced between the groups. One atypical femoral fracture and two cases of osteonecrosis of the jaw were observed in the romosozumab group. CONCLUSIONSIn postmenopausal women with osteoporosis, romosozumab was associated with a lower risk of vertebral fracture than placebo at 12 months and, after the transition to denosumab, at 24 months. The lower risk of clinical fracture that was seen with romosozumab was evident at 1 year. (Funded by Amgen and UCB Pharma; FRAME ClinicalTrials.gov number, NCT01575834.)

In postmenopausal women with low bone mass, romosozumab was associated with increased bone mineral density and bone formation and with decreased bone resorption. (Funded by Amgen and UCB Pharma; ClinicalTrials.gov number, NCT00896532.).

The use of synthetic mesh to augment vaginal repair procedures for pelvic organ prolapse has increased in large part because of dissatisfaction with the success rates of traditional colporrhaphy. Its use, however, is controversial. Four randomized controlled studies comparing traditional colporrhaphy with vaginal repair using mesh augmentation had conflicting results. This unblinded, prospective, randomized controlled trial investigated whether mesh augmentation during vaginal repair would reduce the rate of recurrent prolapse at 12 months compared with traditional colporrhaphy. A total of 139 women with stage 2 or more prolapse who required both anterior and posterior compartment repair were randomized to mesh augmentation (mesh group, n ϭ 69) or colporrhaphy (no mesh group, n ϭ 70). Study subjects were enrolled between 2003 and 2005 at a tertiary teaching hospital. Prolapse was staged using the pelvic-organ-prolapse quantification (POP-Q) system. The primary study outcome was objective success of surgery defined as the absence of POP-Q stage 2 or more prolapse at 12 months following surgery. Questionnaires were used to assess secondary outcomes including symptoms, quality of life, and patient satisfaction.Of the 139 women, 63 of 69 (93.1%) in the mesh group and 61 of 70 (87.1%) in the no mesh group attended the 12-month follow-up. There was no significant difference at 12 months in objective success (POP-Q stage 0 or 1) between the mesh and no mesh groups (mesh: 81.0% ͓51/63͔ vs. no mesh: 65.6% ͓40/61͔; P ϭ 0.07). Although patients in both groups expressed a high level of satisfaction with the surgery and improved symptoms and parameters of quality of life compared to baseline, there was no statistically significant difference in these outcomes between the 2 groups (P ϭ ns). Postoperative complications in the mesh group included four cases (5.6%) of vaginal mesh exposure. At 12 months, de novo dyspareunia was reported in 27.8% (5/18) of the sexually active women without preoperative dyspareunia in the mesh group and in 41.7% (5/12) of those in the no mesh group. These differences were not significant (P ϭ 0.46).These findings show that anterior and posterior vaginal repair with mesh augmentation at 12 months after surgery does not result in significantly less recurrent prolapse than traditional colporrhaphy. GYNECOLOGY Volume 64, Number 12 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACTThe presence of myomas can impair fertility. To preserve fertility in women with myomas wanting to become pregnant, myomectomy can be performed with laparotomy, laparoscopy, or hysteroscopy and achieve pregnancy rates of up to 70%. Advantages of laparoscopic techniques compared with laparotomy include shorter hospital stay, more rapid recovery, and less intra-abdominal adhesions. In addition, the overall complication rate is lower. Precise dissection and suturing, however, is especially difficult with traditional laparoscopy for myomas with a deep intramural and/or another unfavorable localization that have a probable impact on fec...