Faculty Bibliography

OBJECTIVE: Vertebral fracture is the most common clinical manifestation of osteoporosis and is significantly associated with an increased risk of future fractures.1 Bone mineral density has traditionally been the best predictor of fragility fractures, however, lean mass may have a greater contribution to the risk of fracture than previously understood. Dual-energy X-ray absorptiometry (DXA) allows for highly accurate measurements of bone mass as well as both fat and lean body mass. The primary objective of this study is to determine if there is an association between lean body mass and the incidence of vertebral fragility fractures in postmenopausal women. The presence of an association between number of vertebral fractures and T-score, Z-score, body mass index (BMI), muscle mass index (lean mass (kg)/ height (m²)), and fat mass are secondary outcome measures. DESIGN: Retrospective cohort study. MATERIALS AND METHODS: All women between the ages of 40 and 100 years, who underwent body composition and bone density testing using DXA scan at the NYU Bone Density and Body Composition Unit from May 2011 to November 2014 were identified. All indications were included. Patients with DXA that did not include a lateral vertebral assessment were excluded. Parametric variables were confirmed by Shapiro-Wilk testing and compared by analysis of variance (ANOVA). Chi-square testing was used for nominal variables. RESULTS: A total of 358 women met inclusion criteria. The average age was 70.2 years +/-10.3 (Range 46 to 93 years), average weight was 139.6lbs +/- 25.9 (Range 90 to 267 lbs) and average body mass index (BMI) was 25.0 +/- 4.5 kg/m² (Range 16.7 to 42.3). A total of 124 vertebral fractures were identified in 85 patients (23.7%), with an average of 0.35 (+/- 0.7) vertebral fractures per patient. Both lean body mass and Z-score were noted to have an inverse association with number of vertebral fractures (p=0.03 and p=0.02, respectively). Women without vertebral fractures had an average lean mass of 62.4 lbs (+/-8.5) (average BMI 24.9 +/-4.5), while women with 3 vertebral fractures had an average lean mass of 59.5 lbs (+/-8.7) (average BMI 26.0 +/-4.5). Women with at least one vertebral fracture were more likely to have an average T-score of at least -0.8 (+/-1.5), but T-score was not found to be significantly associated with number of fractures (p=0.26). Additionally, fat mass (p=0.82), BMI (p=0.19), and muscle mass index (p=0.36) did not prove to be predictive of vertebral fracture in this population. CONCLUSIONS: Irrespective of BMI, a lean mass of greater than 62.4lbs was associated with lower incidence of vertebral fracture in our population. These results suggest the importance of assessing lean mass in postmenopausal women, as it is a modifiable risk factor for osteoporotic fractures

The Women's Health Initiative (WHI) assessed the long-term effects of hormone therapy (HT) in postmenopausal women. The WHI started HT treatment on women aged 50-79 years in order to ascertain these effects. The study was ended early, due to findings of increased risk of coronary heart disease, breast cancer, stroke, and thromboembolic complications in women receiving estrogen plus progestin, compared to placebo. An increased risk of thromboembolic complications was also demonstrated in the estrogen only component of the WHI. The WHI results were initially reported for all subjects, and showed little difference when data were not analyzed by age. New WHI sub-analyses stratifying results by age, and an extended follow-up of the WHI offer a more complete picture of the effects of HT, revealing that starting HT in postmenopausal women less than ten years from last menstrual period appears to have less risk. In addition, hysterectomized women treated with estrogen only in the WHI have showed less risk of adverse outcomes than women in the estrogen plus progestin group. In this paper, we review data supporting the use of HT administered to postmenopausal women, showing it to have more benefit than risk for symptom control, prevention of bone mineral loss and fracture, and improvement of the metabolic profile in women who began HT when they were less than 60 years of age and had their last menstrual period less than ten years previous. In hysterectomized women treated with estrogen only, a reduction in breast cancer risk was noted in all age groups. The WHI raised many important questions. Ten years later, some have been answered, including confirmation that HT for most newly menopausal women is safe and effective. The treatment of the aging woman, including hormone treatment after menopause, should remain one of our highest research priorities. This article is part of a Special Issue entitled 'Menopause'.

OBJECTIVE: The results of the Women's Health Initiative studies dramatically altered hormone therapy use around the world. In countries outside the United States, self-use in physicians remained unaltered while prescription use declined, implying that physicians may not concur with the findings. We wished to explore prevailing attitudes among American physicians by examining New York City obstetrician-gynaecologists' self-use and prescription use of hormone therapy. STUDY DESIGN: All board-certified obstetrician-gynaecologists in New York City were invited to complete and return a detailed, previously validated questionnaire concerning hormone therapy use. RESULTS: Two hundred and nine questionnaires were returned, for a response rate of 12% (209/1797). Gynaecologists agreed with the findings from the Women's Health Initiative studies regarding indications and contraindications to hormone therapy use. Even so, three-quarters of female gynaecologists and female partners of male gynaecologists (74%; 67/91) use or have previously used hormone therapy. However, only 27.3% (21/77) of male gynaecologists and 12.3% (14/114) of female gynaecologists recommend hormone therapy to all menopausal women regardless of contraindications. Gynaecologists remain divided in their attitude toward hormone therapy; 30% of gynaecologists felt that hormone therapy use generally prolonged women's lives, 36% felt it was not useful in prolonging women's lives, and 33% were unsure. CONCLUSION: Since the publication of the Women's Health Initiative findings, New York City gynaecologists prescribe hormone therapy to fewer patients. However, they continue to self-use hormone therapy at much higher rates, even as they seem to concur with Women's Health Initiative recommendations, contributing to the ongoing controversy surrounding the validity of the Women's Health Initiative findings.

Objective: Symptomatic vaginal atrophy affects one out of three menopausal women. Hormone therapy, both systemic and local, is effective and indicated for the relief of this problem but may not be acceptable to all patients. DT56a (Femarelle), a selective estrogen receptor modulator derived from botanical source, was found to be effective at decreasing menopausal hot flushes and increasing bone mass. We performed a pilot study testing the use of DT56a for vaginal atrophy. Design: 12 post-menopausal women with vaginal atrophy (<5% superficial cells on cervical cytology) with at least one moderate-to-severe symptom, were recruited for an TRB-approved 12-week open-label pilot study. DT56a (322mg) was given by mouth 2X/day for 12 weeks. At each visit (0&q4 weeks) subjects had a vaginal atrophy assessment (speculum exam, vaginal pH) and completed questionnaires on atrophy symptoms and quality of life (Utian QoL scale).At weeks 0 and 12, a pap smear with maturation index and vaginal cultures were performed. Results: The main bothersome symptoms were: Dyspareunia- 5 Patients,Vaginal soreness- 3 Patients.Vaginal dryness- 2 Patients.Vaginal irritation-1 Patient and Bleeding with coitus-1 Patient. All patients reported significant improvement in their most bothersome symptom. All women had a significant reduction in vaginal pH. The average pH went from baseline 7.7+/-2.2 to 4.9+/-1.4 on week 12,p<0.0001. The maturation index also improved as shown in the figure below: Parabasal cells that were 100% at entry were 43% following 12 weeks of treatment, Intermediate cells were changed from 0 to 47% and Superficial cells that were 0 at entry, were 10% following 12 weeks of treatment with DT56a (all statistically significant, p<0.001). A significant improvement was found in UQoL index from mean pre-treatment of 75.4+/-22.7 points to mean post-treatment of 88.9+/-26.8, p<0.001.In the sexual domains of the UQoL there was a significant improvement from 6.5+2 points (mean pre-treatment) to 10.6+ 3.2 (mean post-treatment), p<0.001. Conclusion: In this open-label prospective study DT56a was effective against symptomatic vulvo-vaginal atrophy in both subjective and objective measures. The changes in symptoms and pH were prompt and paralleled symptomatic relief. DT56a furnished a significant improvement in UQoL. As the placebo effect on the maturation index and vaginal pH is negligible, this 12 patient study provides an indicative measurement of the positive effect of DT56a for the treatment of vulvo-vaginal atrophy and a large double blind placebo controlled trial is planned. (Table presented)