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Abstract: There are numerous causes of secondary osteoporosis including endocrine disorders, nutritional deficiencies, and other miscellaneous conditions and medications. It is essential to identify and address these factors to appropriately manage patients with osteoporosis. Failure to do so may result in further bone loss despite pharmacologic intervention for osteoporosis. The following diagnostic studies should be considered initially: complete blood count, complete metabolic panel, 25-hydroxyvitamin D level, testosterone level in men, and 24-hour urinary calcium, sodium, and creatinine. Further testing may be performed in selected patients depending on the clinical picture and results of the initial workup. [ABSTRACT FROM AUTHOR]

The article provides information on the "Clinician's Guide to Prevention and Treatment of Osteoporosis." These guidelines, which are developed by the World Health Organization Fracture Risk Assessment Tool and the National Osteoporosis Foundation (NOF), are helpful clinical tools in the management of osteoporosis.

The first bisphosphonate (etidronate) was approved by the FDA in 1977; alendronate was approved in 1995 for the prevention and treatment of osteoporosis. Bisphosphonates have emerged as the agents of choice for the treatment of osteoporosis and have proved useful in the treatment of skeletal complications of malignancy (hypercalcemia, bone metastases) and have been used long-term in millions of patients. Osteonecrosis of the jaw (ONJ) is a newly described condition (2003) defined as exposed bone in the maxillofacial area, not associated with radiation or any other known cause and not healing for 8 weeks. Most cases have followed dental extraction, another invasive dental procedure, or poorly fitting dentures. Although most cases are painful and it can be progressive, approximately one-third of cases are painless and some do resolve. Although ONJ occurs exclusively or almost exclusively in patients receiving bisphosphonate therapy, a causal association has not been shown, and the mechanism is not clear. In patients receiving high-dose IV bisphosphonates for malignant diseases, ONJ may occur in 5 to 10% over 3 years. It does occur in patients receiving oral or IV bisphosphonates for osteoporosis, but is rare in that setting; about 1 case per 100,000. Treatment is conservative (antimicrobial mouthwash, antibiotics for secondary infection, limited debridement). Preventive strategies should include good dental hygiene for all patients and completion of elective invasive dental procedures before initiating high-dose IV bisphosphonate therapy for cancer. Patients with osteoporosis receiving lower-dose bisphosphonate therapy do not require special precautions, but should be informed of the low risk of this complication. [ABSTRACT FROM AUTHOR]

Editorial. Presents several editorials on the use of hormone replacement therapy (HRT) at the Women's Health Initiative study in the U.S. as of September 2002. Reasons of women for taking HRT; Adverse effects of HRT; Benefits of estrogen therapy.

The article discusses the diagnosis and evaluation of patients with Osteoporosis. Osteoporosis is a silent condition characterized by reduced bone mass and abnormal bone architecture, with an associated increase in the risk of fractures. Biochemical markers of bone turnover may be useful to decide if treatment is needed and to determine the effectiveness of treatment. Osteoporosis in adults is commonly caused by estrogen deficiency and aging. However, bone loss may be secondary to a variety of diseases and conditions. Bone biopsy should be considered in patients who have unusual features of osteoporosis, men and young women who have osteoporosis, patients who have very low bone mass, patients who have fragility fractures but normal bone mass and patients failing conventional therapy.

Osteoporosis is a condition that affects approximately 44 million Americans and is characterized by reduced bone mass and an increased risk of fractures. Of the 1.5 million osteoporotic fractures in the United States each year, vertebral fractures are the most common, while hip fractures are the most serious, with 10-20% of those victims dying within one year. The articles focus on the available methods of diagnosing osteoporosis, the existing treatment options, the importance of self-management and low bone mineral density, and the prevention of glucocorticoid-induced osteoporosis.

Objective: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.Methods: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies.Results: From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}.Conclusion: Up to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy.Clinical Trial Registration: ClinicalTrials.gov, NCT02925494.Funding Source: AbbVie Inc funded this study. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study of the Own the Bone database which is a fracture liaison service designed to improve recognition and treatment of osteoporosis.Objective: To use the Own the Bone (OTB) database to 1) examine the specific demographics of patients presenting with a low-energy clinical vertebral fracture (VFX) and 2) compare demographic and fracture-specific risk factors between patients with clinical VFX versus patients with nonvertebral low-energy fracture (NVFX).Summary Of Background Data: Large database studies have described risk factors for developing VFX. It is well described that a history of previous VFX portends an increased risk of future VFX. Few studies have reported cohorts from a fracture liaison service such as the OTB initiative.Methods: 35,039 unique cases of fragility fracture occurred between 2009 and 2016 and were included in analysis. VFX accounted for 3395 (9.9%) of the presenting fractures at OTB enrollment. The demographics, lifestyle factors, medication use, and fracture-specific data for patients in the OTB registry with vertebral fractures were summarized and then statistically compared to those with nonvertebral fragility fractures.Results: The majority of VFX patients were Caucasian, postmenopausal women (74.4%). There was an increased likelihood of presenting with a vertebral fracture in patients who sustained a previous VFX after the age of 50, while patients who sustained a prior nonvertebral fracture (NVFX) were more likely to present with a subsequent NVFX. After controlling for patients with a history of fracture after the age of 50, VFX patients (vs. NVFX) were more likely to be age 70-79, class 1 obesity, with a history of taking anti-osteoporotic prescription medications.Conclusions: Multiple factors were associated with a significantly increased risk of VFX compared with NVFX. Understanding the risk factors unique to fragility VFX is a critical component for targeting "at-risk" patients and preventing future osteoporosis-related fractures and their consequences.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Objective: To evaluate elagolix, an oral gonadotropin-releasing hormone receptor antagonist, alone or with add-back therapy, in premenopausal women with heavy menstrual bleeding (greater than 80 mL per month) associated with uterine leiomyomas.Methods: This double-blind, randomized, placebo-controlled, parallel-group study evaluated efficacy and safety of elagolix in cohorts 1 (300 mg twice daily) and 2 (600 mg daily) with four arms per cohort: placebo, elagolix alone, elagolix with 0.5 mg estradiol/0.1 norethindrone acetate, and elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate. A sample size of 65 per group was planned to compare elagolix with add-back to placebo on the primary end point: the percentage of women who had less than 80 mL menstrual blood loss and 50% or greater reduction in menstrual blood loss from baseline to the last 28 days of treatment. Safety assessments included changes in bone mineral density.Results: From April 8, 2013, to December 8, 2015, 571 women were enrolled, 567 were randomized and treated (cohort 1=259; cohort 2=308), and 80% and 75% completed treatment, respectively. Participants had a mean±SD age of 43±5 years (cohort 2, 42±5 years), and 70% were black (cohort 2, 74%). Primary end point responder rates in cohort 1 (cohort 2) were 92% (90%) for elagolix alone, 85% (73%) for elagolix with 0.5 mg estradiol/0.1 mg norethindrone acetate, 79% (82%) for elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate, and 27% (32%) for placebo (all P<.001 vs placebo). Elagolix groups had significant decreases compared with placebo in lumbar spine bone mineral density, which was attenuated by adding 1.0 mg estradiol/0.5 mg norethindrone acetate.Conclusion: Elagolix with and without add-back significantly reduced menstrual blood loss in women with uterine leiomyomas. Add-back therapy reduced hypoestrogenic effects on bone mineral density.Clinical Trial Registration: ClinicalTrials.gov, NCT01817530; EU Clinical Trial Register, 2013-000082-37. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain.Methods: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate.Results: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV 550.8%) and 78.2% at 200 mg twice daily (Elaris EMIV 575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.5% at 150 mg once daily (Elaris EM-IV 566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV 567.2%).”After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings.Conclusion: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.Clinical Trial Registration: ClinicalTrials.gov, NCT01760954 and NCT02143713. [ABSTRACT FROM AUTHOR]

To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. METHODS: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebocontrolled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate. RESULTS: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV550.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV567.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV545.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV558.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings. CONCLUSION: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use. [ABSTRACT FROM AUTHOR]

The article focuses on proper handling and long-term care of patients suffering from osteoporosis with prior fracture. It states that the proper management of the disease is critical to prevent risks for recurrent fractures. The World health Organization (WHO) has introduced fracture prediction algorithm (FRAX) to be able to absolutely predict fracture risks using the body mass index of the patient. Discussions of the other possible therapies that may be applied for osteoporosis are provided.

Osteoporosis is a growing health concern as the number of senior adults continues to increase worldwide. Falls and fractures are very common among frail older adults requiring home health and long-term care. Preventative strategies for reducing falls have been identified and many therapies (both prescription and nonprescription) with proven efficacy for reducing fracture risk are available. However, many practitioners overlook the fact that a fragility fracture is diagnostic for osteoporosis even without knowledge of bone mineral density testing. As a result, osteoporosis is infrequently diagnosed and treated in the elderly after a fracture. Based on existing literature, we have developed an algorithm for the assessment and treatment of osteoporosis among persons with known prior fracture(s) living in long-term care facilities or receiving home health care based on the data available in the literature. [ABSTRACT FROM AUTHOR]

This article highlights results of Position Development Conference in Denver, Colorado, between July 20-22, 2001 which was convened by the International Society for Clinical Densitometry on a controversy related to the interpretation on bone densitometry. Bone densitometry is routinely used to assess the skeleton in patients who have diseases or conditions that can cause low bone mass. When making a diagnosis of osteoporosis using dual x-ray absorptiometry, bone mineral density (BMD) of bath the spine and hip should be measured. BMD of the first four lumbar vertebrae should be measured whenever possible.