Outcomes Of Raloxifene Evaluation Study Research Articles

Psychometric properties of the osteoporosis assessment questionnaire (OPAQ) 2.0: results from the multiple outcomes of raloxifene evaluation (MORE) study.

BackgroundWe explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis.MethodsThe Multiple Outcomes of Raloxifene Evaluation study was a randomized, placebo-controlled, multinational clinical trial evaluating efficacy and safety of raloxifene. The Osteoporosis Assessment Questionnaire 2.0, a generic quality of life measure (Nottingham Health Profile), and a preference-based measure (Health Utilities Index) were administered at baseline and annually. Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques.ResultsThis study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires. Mean (standard deviation) age was 68.4 (6.8) years. Prevalent vertebral fractures were found in 70% (n =1038) of women. Internal consistency was >0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains. Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores, Nottingham Health Profile domains, and Health Utilities Index scores. All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures. Women with ≥1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores (excluding social activity and support of family and friends) from baseline to study endpoint compared with women without incident vertebral fractures.ConclusionsMost domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties; however, several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2474-15-374) contains supplementary material, which is available to authorized users.

Use of health-related quality of life measures to predict health utility in postmenopausal osteoporotic women: results from the Multiple Outcomes of Raloxifene Evaluation study

BackgroundThe aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women.MethodsBaseline data from a subsample of 1,245 participants of the Multiple Outcomes of Raloxifene Evaluation study, a randomized, placebo-controlled, multinational clinical trial to evaluate the safety and efficacy of raloxifene, were analyzed. The study cohort included 694 participants from non-European Union (non-EU) countries and 551 participants from EU countries. All participants with complete baseline HU and HRQoL assessments were included in the following analyses: 1) HU (HUI or EQ-5D) and HRQoL (QualEFFO or OPAQ and NHP) associations; 2) HU variability explained by HRQoL domains; and 3) the percentage of HU variability explained by statistically significant (p < 0.05) HRQoL domains, after adjusting for baseline characteristics.ResultsSeveral domains were significantly associated with HU scores. HU variance was well explained (41% to 61%) by 4 to 6 (p < 0.05) significant HRQoL domains. After controlling for baseline characteristics, 48% to 64% of the HU variance was well explained by 5 to 7 significant (p < 0.05) HRQoL domains. Additional trend analyses detected statistically significant decreases in HRQoL and HU scores with an increased number of vertebral and non-vertebral fractures.ConclusionsBoth disease-targeted and generic HRQoL domains were well correlated with HU. A large percentage (48% to 64%) of the HU variance was explained by HRQoL, after adjusting for baseline characteristics. Both disease-targeted and generic HRQoL measures were significant predictors of HU. HRQoL and HU scores decreased with increased vertebral and non-vertebral fractures.

Another chapter for vertebral compression fractures

Every year, 1·4 million patients present with vertebral compression fractures worldwide. 1 Johnell O Kanis JA An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006; 17: 1726-1733 Crossref PubMed Scopus (2858) Google Scholar These fractures cause pain, disability, and diminished quality of life, 2 Borgstrom F Zethraeus N Johnell O et al. Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int. 2006; 17: 637-650 Crossref PubMed Scopus (244) Google Scholar , 3 Silverman SL Minshall ME Shen W Harper KD Xie S on behalf of the Health-Related Quality of Life Subgroup of the Multiple Outcomes of Raloxifene Evaluation StudyThe relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum. 2001; 44: 2611-2619 Crossref PubMed Scopus (294) Google Scholar and are associated with an increased risk of future vertebral fractures. 4 Lindsay R Silverman SL Cooper C et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001; 285: 320-323 Crossref PubMed Scopus (1447) Google Scholar Most of these fractures are due to osteoporosis and occur spontaneously or with minimum trauma, and the vertebrae heal in a deformed state with non-surgical management that includes analgesia, bed rest, physiotherapy, and back bracing. Pain can resolve slowly and persist. 5 Lyritis GP Mayasis B Tsakalakos N et al. The natural history of the osteoporotic vertebral fracture. Clin Rheumatol. 1989; 8: 66-69 Crossref PubMed Scopus (106) Google Scholar Further fractures result in vertebral deformity, height loss, kyphosis, decreased pulmonary function, and mobility and balance impairment. 5 Lyritis GP Mayasis B Tsakalakos N et al. The natural history of the osteoporotic vertebral fracture. Clin Rheumatol. 1989; 8: 66-69 Crossref PubMed Scopus (106) Google Scholar , 6 Schlaich C Minne HW Bruckner T et al. Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int. 1998; 8: 261-267 Crossref PubMed Scopus (417) Google Scholar , 7 Lyles KW Gold DT Shipp KM Pieper CF Martinez S Mulhausen PL Association of osteoporotic vertebral compression fractures with impaired functional status. Am J Med. 1993; 94: 595-601 Summary Full Text PDF PubMed Scopus (358) Google Scholar What is the point of surgery?On an individual level, surgery relieves pain, restores function, improves quality of life, and saves lives. In what manner and to what end do these services engage in broader terms with the health of populations? 1 year ago, The Lancet published a surgery-themed issue that introduced the IDEAL recommendations to improve surgical research. In that issue, Ara Darzi and colleagues challenged surgeons to transform their specialty into a word-class discipline. Today's Lancet returns to the theme of surgery to assess what progress has been made. Full-Text PDF Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trialIn a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. Full-Text PDF

Effect of long-term treatment with raloxifene on mammary density in postmenopausal women

To evaluate in a group of postmenopausal women the effects of long-term raloxifene treatment on breast density using a digitized analysis of mammograms and on insulinlike growth factor-1 (IGF-1), insulinlike growth factor binding protein-3 (IGFBP-3), and sex hormone-binding globulin (SHBG) plasma levels. Seventy healthy postmenopausal women with normal body weight were enrolled in this study and were divided into two groups based on their bone status, evaluated by dual-energy x-ray at the lumbar spine (L2-4). Fifty women (chronological age 52.4 +/- 4.1 y, menopausal age 42.1 +/- 3.9 y), in whom the L2-4 T score was less than -2.5 SD, were treated with raloxifene HCl 60 mg/day orally for 2 years. The other 20 women (chronological age 53.6 +/- 3.5 y, age at menopause 43.1 +/- 3.6 y), in whom the L2-4 T score ranged between -1 and -2.5 SD, were enrolled as controls. All 70 women received calcium (1 g/d orally) and cholecalciferol (880 UI/d orally) supplementation. Moreover, all women followed a normocaloric and personalized diet. All women had mammography at baseline and after 2 years of therapy. The mammographic images on traditional support (radiography) were acquired by using a film scanner and were then elaborated by means of ad hoc software. Moreover, assessments of IGF-1, IGFBP-3, and SHBG plasma levels were obtained at baseline and after 24 months. After 24 months of therapy, there was a significant variation in the raloxifene-treated group with respect to baseline in the distribution of gray classes of radiographic images. In particular, an attenuation of graphic trace with a reduction of the areas with the lowest and most elevated gray classes was observed. In the control group, no significant variations of graphic traces were observed. Moreover, raloxifene treatment significantly reduced IGF-1 and increased IGFBP-3 and SHBG plasma levels at 24 months. During follow-up, IGF-1, IGFPB-3, and SHBG levels did not change significantly in the control group. Long-term treatment with raloxifene in a population of postmenopausal women is able to reduce breast density. Such an effect could perhaps explain the reduction in the incidence of mammary carcinoma observed in the Multiple Outcomes of Raloxifene Evaluation study probably due to the direct antiestrogenic activity of raloxifene on mammalian tissue and/or its indirect activity increasing SHBG levels or modifying the IGF-1/IGFBP-3 ratio.

Skeletal and nonskeletal effects of raloxifene

Raloxifene, a selective estrogen receptor modulator, is approved for the prevention and treatment of postmenopausal osteoporosis. Prevention studies with raloxifene have demonstrated preservation of bone density and suppression of bone turnover markers in young postmenopausal women. The Multiple Outcomes of Raloxifene Evaluation study was the pivotal treatment trial for raloxifene. It demonstrated significant reduction in the risk for vertebral fractures after 1 and 3 years. Significant reduction of nonvertebral fractures with raloxifene has not yet been demonstrated. In addition to the effects of raloxifene on bone, potentially beneficial effects on the cardiovascular system, breast, and uterus have been described. Most of these nonskeletal effects have been reported as secondary endpoints from large osteoporosis trials with raloxifene. Prospective, randomized, double-blind studies of raloxifene with breast cancer prevention and cardiovascular protection as primary endpoints are now underway.

The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study.

To examine the effect of both prevalent and incident vertebral fractures on health-related quality of life (HRQOL) in postmenopausal women with osteoporosis and to characterize the effect of prevalent vertebral fractures on HRQOL with respect to number, location, severity, and adjacency. Participants were a subset of women (n = 1,395, mean age 68.5 years) from the Multiple Outcomes of Raloxifene Evaluation trial who had low bone mineral density and/or prevalent vertebral fractures. Vertebral fractures were measured by radiography at baseline, 2 years, and 3 years. HRQOL was assessed using the Osteoporosis Assessment Questionnaire (OPAQ), a validated disease-targeted instrument, at baseline and annually for 3 years. Both prevalent and incident radiographic vertebral fractures were associated with decreased HRQOL. At baseline, women with a prevalent vertebral fracture had significantly lower OPAQ scores on physical function, emotional status, clinical symptoms, and overall HRQOL compared with women without a prevalent fracture (all P < 0.01). HRQOL scores were lower with each subsequent fracture. The effect of prevalent vertebral fracture was dependent on the location within the spine and was strongest in the lumbar region (L1-L4). Incident vertebral fractures significantly decreased OPAQ scores on physical function, emotional status, clinical symptoms, and overall HRQOL (all P < 0.001). Our findings demonstrate the importance of treating postmenopausal women who have prevalent vertebral fractures to prevent further decreases in HRQOL associated with subsequent incident vertebral fracture.