- Email: [email protected]
100 RELIABILITY AND VALIDITY OF THE CERVANTES HEALTH-RELATED QUALITY-OF-LIFE SCALE IN SPANISH ELDERLY POST-MENOPAUSAL WOMEN
9th European Congress on Menopause and Andropause / Maturitas 71, Supplement 1 (2012) S1–S82
98 GROUND REACTION FORCES OF POSTMENOPAUSAL WOMEN: INFLUENCE OF HEEL BONE MINERAL DENSITY AND REGIONAL SOFT LEAN MASS M.H. Moreira 1 , R.E. Gabriel 2 , A. Leite 3 , F.R. Aragão 4 , J. Fonseca 5 , M. Pereira 6 , J.A. Faria 7 . 1 Department of Sport Sciences, Exercise and Health CIDESD, University of Tras-os-Montes and Alto Douro; 2 Department of Sport Sciences, Exercise and Health - CITAB, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal; 3 Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, Brazil; 4 Department of Sport Sciences, Exercise and Health - CIDESD, University of Trás-os-Montes and Alto Douro, Vila Real; 5 Faculty of Engineering of University of Porto, Porto; 6 Advanced Polytechnic and University Cooperative, Gandra; 7 Department of Sport Sciences - CIDESD, University of Beira Interior, Covilhã, Portugal Ground reactions forces (GRF) indicate the magnitude and duration of the load applied on the musculoskeletal system when in contact with the ground. Those can be determinants of potential injury, for instance, in the presence of bone weakness. The purpose of this study was to investigate the influence of body composition in vertical and anterior-posterior GRF, during walking of postmenopausal women (PW). A total of 65 healthy PW aged 48–69 years were included in the study. Regional soft lean mass (SLM; arms, trunk and legs) and basal metabolic rate (BMR) were evaluated by bioimpedance. Bone mineral density was measured by ultrasound in the heel area (BMDH ) and a low value was considered to T-score ≤-1.0. The GRF data were collected using force platform and the durations, amplitudes and impulses were determined. The stepwise regression models were developed to assess the influence of age, BMR and regional SLM in biomechanical variables and t test for independent samples was used to compare groups. The BMDH was an independent predictor of stance duration (β=0.267, p≤0.05), maximum vertical force in early stance phase, braking impulse duration, braking impulse (β=−0.364, p≤0.01), propulsive impulse and vertical unloading rate. The mean values of those variables were not significantly different between the PW with low bone mineral density (n= 29) and normal bone condition. These results suggest an influence of BMDH on the GRF patterns and on the load put on the musculoskeletal system. Using the WHO densitometric criteria no differences were identified in these parameters.
99 REPRODUCTIVE SAFETY OF BAZEDOXIFENE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS: RESULTS OF A 7-YEAR, RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3 STUDY S. Palacios 1 , T.J. de Villiers 2 , F. De Cicco-Nardone 3 , A. Levine 4 , R. Williams 4 , T. Hines 4 , A.A. Chines 4 . 1 Instituto Palacios, Madrid, Spain; 2 Panorama MediClinic and University of Stellenbosch, Cape Town, South Africa; 3 Università Cattolica del Sacro Cuore, Rome, Italy; 4 Pfizer Inc, Collegeville, PA, USA Objective: To describe the reproductive safety of bazedoxifene (BZA) over 7 years of treatment. Design: This was a second 2-year extension (N=1,732, Years 6-7) of a 3-year, randomized, phase 3 study in postmenopausal women with osteoporosis. In the core study (N=7,492), subjects received BZA 20 or 40 mg, raloxifene 60 mg, or placebo. During Extension I (N=4,216, Years 4-5), the raloxifene group was discontinued and subjects receiving BZA 40 mg were transitioned to BZA 20 mg. In Extension II, the study remained
S51
double-blinded and BZA-treated subjects continued receiving BZA 20 mg. Findings at 7 years are reported for BZA 20 mg, BZA combined (all BZA-treated subjects), and placebo. Results: BZA showed a favorable reproductive safety profile at 7 years, consistent with findings at 3 and 5 years (Table). The mean change (±standard error) from baseline in endometrial thickness was similar among groups (−0.23±0.25 mm [BZA 20 mg], −0.15±0.18 mm [BZA combined], 0.14±0.56 mm [placebo]). The BZA groups showed significantly lower endometrial carcinoma rates than placebo (P<0.05). Incidences of endometrial hyperplasia and breast carcinoma were similar among groups. The BZA groups showed numerically higher incidences of histopathologically confirmed ovarian carcinoma than placebo (not statistically significant). Incidences of other reproductive AEs were similar among groups. Conclusion: BZA showed a favorable breast and endometrial safety profile over 7 years.
100 RELIABILITY AND VALIDITY OF THE CERVANTES HEALTH-RELATED QUALITY-OF-LIFE SCALE IN SPANISH ELDERLY POST-MENOPAUSAL WOMEN S. Palacios 1 , J.L. Neyro 2 , S. Fernández de Cabo 3 , J. Rejas 4 . 1 Instituto Palacios de Salud y Medicina de la Mujer, Madrid; 2 Department of Obstetrics and Gynecology, Hospital Universitario de Cruces, Baracaldo; 3 Medical Unit, Pfizer, S.L.U., Alcobendas; 4 Health Economics and Outcomes Research, Pfizer, Madrid, Spain Objective: To explore the psychometric properties of the menopausespecific Cervantes scale in elderly post-menopausal women older than 64 years. Methods: We analyzed a random sub-sample of women older than 64 years who were enrolled in a cross-sectional, epidemiological study including post-menopausal women attending outpatients clinics of Gynecology in Spain. Along with the self-administered 31-items Cervantes scale, the Spanish version of the SF-12v2 and socio-demographics data were also recorded. Feasibility, reliability, criterion and construct validities were explored. Results: 312 post-menopausal women [mean (SD) age of 69.7 (4.2) years (range: 65-87) were included. Missing questionnaires was very low; 0.63%. Ceiling effect was negligible, while floor effect was observed in item #24 (51.6%) and #17 (47.1%). Cronbach’s α coefficients were above 0.7 in all cases; ranging from 0.915 (whole scale) to 0.708 (aging sub-domain). The scale correlated high and significantly with mental and physical summary components of the SF-12v2; −0.713 and −0.608, respectively (p<0.001). Vascular symptoms, sexual and partner relationship domains showed poor negative correlations with SF-12v2 (−0.09 to −0.38), while the other domains showed negative and high to moderate correlations (−0.43 to −0.71, p<0.01). The scale was able to differentiate HRQoL of subjects with different co-morbidities that were expected to be different and to discriminate between subjects with scoring in the 1st and 4th interquartil intervals of the total scale; 34.1 versus 88.8, p<0.001. Conclusions: The Cervantes Scale showed appropriate psychometric properties of feasibility, internal consistency and validity to explore HRQL of post-menopausal elderly women older than 64 years of age.
101 HEALTH-RELATED QUALITY-OF-LIFE IN POST-MENOPAUSAL WOMEN WITH OSTEOPOROSIS AND METABOLIC SYNDROME S. Palacios 1 , J.L. Neyro 2 , S. Fernández de Cabo 3 , J. Chaves 3 , J. Rejas 4 . 1 Instituto de Salud y Medicina de la Mujer, Madrid; 2 Department of Obstetrics and Gynecology, Hospital Universitario de Cruces, Baracaldo; 3 Medical Unit; 4 Health Economics and Outcomes Research, Pfizer S.L.U., Alcobendas, Madrid, Spain Objective: To investigate the impact of co-morbid metabolic syndrome (MS) on Health-Related Quality-of-Life (HRQoL) in post-menopausal women with osteoporosis. Methods: A cross-sectional, epidemiological study was designed including post-menopausal women (at least 12-month after last menstrual period) with osteoporosis, above 18-years old, who were attending outpatients clinics of Gynecology. HRQoL was recorded using the menopause specific Cervantes scale (higher score equivalent to worse HRQoL) and the
98 GROUND REACTION FORCES OF POSTMENOPAUSAL WOMEN: INFLUENCE OF HEEL BONE MINERAL DENSITY AND REGIONAL SOFT LEAN MASS M.H. Moreira 1 , R.E. Gabriel 2 , A. Leite 3 , F.R. Aragão 4 , J. Fonseca 5 , M. Pereira 6 , J.A. Faria 7 . 1 Department of Sport Sciences, Exercise and Health CIDESD, University of Tras-os-Montes and Alto Douro; 2 Department of Sport Sciences, Exercise and Health - CITAB, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal; 3 Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, Brazil; 4 Department of Sport Sciences, Exercise and Health - CIDESD, University of Trás-os-Montes and Alto Douro, Vila Real; 5 Faculty of Engineering of University of Porto, Porto; 6 Advanced Polytechnic and University Cooperative, Gandra; 7 Department of Sport Sciences - CIDESD, University of Beira Interior, Covilhã, Portugal Ground reactions forces (GRF) indicate the magnitude and duration of the load applied on the musculoskeletal system when in contact with the ground. Those can be determinants of potential injury, for instance, in the presence of bone weakness. The purpose of this study was to investigate the influence of body composition in vertical and anterior-posterior GRF, during walking of postmenopausal women (PW). A total of 65 healthy PW aged 48–69 years were included in the study. Regional soft lean mass (SLM; arms, trunk and legs) and basal metabolic rate (BMR) were evaluated by bioimpedance. Bone mineral density was measured by ultrasound in the heel area (BMDH ) and a low value was considered to T-score ≤-1.0. The GRF data were collected using force platform and the durations, amplitudes and impulses were determined. The stepwise regression models were developed to assess the influence of age, BMR and regional SLM in biomechanical variables and t test for independent samples was used to compare groups. The BMDH was an independent predictor of stance duration (β=0.267, p≤0.05), maximum vertical force in early stance phase, braking impulse duration, braking impulse (β=−0.364, p≤0.01), propulsive impulse and vertical unloading rate. The mean values of those variables were not significantly different between the PW with low bone mineral density (n= 29) and normal bone condition. These results suggest an influence of BMDH on the GRF patterns and on the load put on the musculoskeletal system. Using the WHO densitometric criteria no differences were identified in these parameters.
99 REPRODUCTIVE SAFETY OF BAZEDOXIFENE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS: RESULTS OF A 7-YEAR, RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3 STUDY S. Palacios 1 , T.J. de Villiers 2 , F. De Cicco-Nardone 3 , A. Levine 4 , R. Williams 4 , T. Hines 4 , A.A. Chines 4 . 1 Instituto Palacios, Madrid, Spain; 2 Panorama MediClinic and University of Stellenbosch, Cape Town, South Africa; 3 Università Cattolica del Sacro Cuore, Rome, Italy; 4 Pfizer Inc, Collegeville, PA, USA Objective: To describe the reproductive safety of bazedoxifene (BZA) over 7 years of treatment. Design: This was a second 2-year extension (N=1,732, Years 6-7) of a 3-year, randomized, phase 3 study in postmenopausal women with osteoporosis. In the core study (N=7,492), subjects received BZA 20 or 40 mg, raloxifene 60 mg, or placebo. During Extension I (N=4,216, Years 4-5), the raloxifene group was discontinued and subjects receiving BZA 40 mg were transitioned to BZA 20 mg. In Extension II, the study remained
S51
double-blinded and BZA-treated subjects continued receiving BZA 20 mg. Findings at 7 years are reported for BZA 20 mg, BZA combined (all BZA-treated subjects), and placebo. Results: BZA showed a favorable reproductive safety profile at 7 years, consistent with findings at 3 and 5 years (Table). The mean change (±standard error) from baseline in endometrial thickness was similar among groups (−0.23±0.25 mm [BZA 20 mg], −0.15±0.18 mm [BZA combined], 0.14±0.56 mm [placebo]). The BZA groups showed significantly lower endometrial carcinoma rates than placebo (P<0.05). Incidences of endometrial hyperplasia and breast carcinoma were similar among groups. The BZA groups showed numerically higher incidences of histopathologically confirmed ovarian carcinoma than placebo (not statistically significant). Incidences of other reproductive AEs were similar among groups. Conclusion: BZA showed a favorable breast and endometrial safety profile over 7 years.
100 RELIABILITY AND VALIDITY OF THE CERVANTES HEALTH-RELATED QUALITY-OF-LIFE SCALE IN SPANISH ELDERLY POST-MENOPAUSAL WOMEN S. Palacios 1 , J.L. Neyro 2 , S. Fernández de Cabo 3 , J. Rejas 4 . 1 Instituto Palacios de Salud y Medicina de la Mujer, Madrid; 2 Department of Obstetrics and Gynecology, Hospital Universitario de Cruces, Baracaldo; 3 Medical Unit, Pfizer, S.L.U., Alcobendas; 4 Health Economics and Outcomes Research, Pfizer, Madrid, Spain Objective: To explore the psychometric properties of the menopausespecific Cervantes scale in elderly post-menopausal women older than 64 years. Methods: We analyzed a random sub-sample of women older than 64 years who were enrolled in a cross-sectional, epidemiological study including post-menopausal women attending outpatients clinics of Gynecology in Spain. Along with the self-administered 31-items Cervantes scale, the Spanish version of the SF-12v2 and socio-demographics data were also recorded. Feasibility, reliability, criterion and construct validities were explored. Results: 312 post-menopausal women [mean (SD) age of 69.7 (4.2) years (range: 65-87) were included. Missing questionnaires was very low; 0.63%. Ceiling effect was negligible, while floor effect was observed in item #24 (51.6%) and #17 (47.1%). Cronbach’s α coefficients were above 0.7 in all cases; ranging from 0.915 (whole scale) to 0.708 (aging sub-domain). The scale correlated high and significantly with mental and physical summary components of the SF-12v2; −0.713 and −0.608, respectively (p<0.001). Vascular symptoms, sexual and partner relationship domains showed poor negative correlations with SF-12v2 (−0.09 to −0.38), while the other domains showed negative and high to moderate correlations (−0.43 to −0.71, p<0.01). The scale was able to differentiate HRQoL of subjects with different co-morbidities that were expected to be different and to discriminate between subjects with scoring in the 1st and 4th interquartil intervals of the total scale; 34.1 versus 88.8, p<0.001. Conclusions: The Cervantes Scale showed appropriate psychometric properties of feasibility, internal consistency and validity to explore HRQL of post-menopausal elderly women older than 64 years of age.
101 HEALTH-RELATED QUALITY-OF-LIFE IN POST-MENOPAUSAL WOMEN WITH OSTEOPOROSIS AND METABOLIC SYNDROME S. Palacios 1 , J.L. Neyro 2 , S. Fernández de Cabo 3 , J. Chaves 3 , J. Rejas 4 . 1 Instituto de Salud y Medicina de la Mujer, Madrid; 2 Department of Obstetrics and Gynecology, Hospital Universitario de Cruces, Baracaldo; 3 Medical Unit; 4 Health Economics and Outcomes Research, Pfizer S.L.U., Alcobendas, Madrid, Spain Objective: To investigate the impact of co-morbid metabolic syndrome (MS) on Health-Related Quality-of-Life (HRQoL) in post-menopausal women with osteoporosis. Methods: A cross-sectional, epidemiological study was designed including post-menopausal women (at least 12-month after last menstrual period) with osteoporosis, above 18-years old, who were attending outpatients clinics of Gynecology. HRQoL was recorded using the menopause specific Cervantes scale (higher score equivalent to worse HRQoL) and the