Index

A

AACE. See American Association of Clinical Endocrinologists

Absorptiometry, dual-energy X-ray, 48

Acetylcholine, 58

Activities of daily living (ADL), 55

Acute urinary retention (AUR), 139

ADL. See Activities of daily living

Adrenopause, 13

Age, in selected studies of endogenous testosterone levels, 35

Age-related changes

in hormones, 12–14

in testosterone levels, 6, 9, 118

Albumin-bound testosterone, 16–17

Alcohol abuse, exclusion criteria, monitoring, and follow-up of research participants for, 145

Alzheimer’s disease, 132–133

American Association of Clinical Endocrinologists (AACE), 22

American College of Pathologists, 123

American Urological Association (AUA), 141–142

Androgen concentrations, 67, 86, 135

potency of, 15

Androgen-metabolizing enzymes, 87

Androgen receptors (ARs), 58, 86

polymorphisms in, 87–88

Andropause, 13, 22

ARs. See Androgen receptors

AUA. See American Urological Association

AUR. See Acute urinary retention

B

Baltimore Longitudinal Study of Aging (BLSA), 33–34, 76, 142–143, 165

BDI. See Beck Depression Inventory

Beck Depression Inventory (BDI), 62, 66

Benefits, communicating to study participants, 6, 9, 118

Benign prostatic hyperplasia (BPH), 5, 81, 86, 118, 138, 142–143

Bioavailable testosterone (BT), 16, 18

BLSA. See Baltimore Longitudinal Study of Aging

BMD. See Bone mineral density

BMI. See Body mass index

Body composition, measures of, 135

Body composition and strength, 47–54

additional studies of testosterone therapy and, 183–184

clinical trials of testosterone therapy and, 49, 50, 52–54

and endogenous testosterone levels, 48–49

Body mass index (BMI), 39



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Testosterone and Aging: Clinical Research Directions Index A AACE. See American Association of Clinical Endocrinologists Absorptiometry, dual-energy X-ray, 48 Acetylcholine, 58 Activities of daily living (ADL), 55 Acute urinary retention (AUR), 139 ADL. See Activities of daily living Adrenopause, 13 Age, in selected studies of endogenous testosterone levels, 35 Age-related changes in hormones, 12–14 in testosterone levels, 6, 9, 118 Albumin-bound testosterone, 16–17 Alcohol abuse, exclusion criteria, monitoring, and follow-up of research participants for, 145 Alzheimer’s disease, 132–133 American Association of Clinical Endocrinologists (AACE), 22 American College of Pathologists, 123 American Urological Association (AUA), 141–142 Androgen concentrations, 67, 86, 135 potency of, 15 Androgen-metabolizing enzymes, 87 Androgen receptors (ARs), 58, 86 polymorphisms in, 87–88 Andropause, 13, 22 ARs. See Androgen receptors AUA. See American Urological Association AUR. See Acute urinary retention B Baltimore Longitudinal Study of Aging (BLSA), 33–34, 76, 142–143, 165 BDI. See Beck Depression Inventory Beck Depression Inventory (BDI), 62, 66 Benefits, communicating to study participants, 6, 9, 118 Benign prostatic hyperplasia (BPH), 5, 81, 86, 118, 138, 142–143 Bioavailable testosterone (BT), 16, 18 BLSA. See Baltimore Longitudinal Study of Aging BMD. See Bone mineral density BMI. See Body mass index Body composition, measures of, 135 Body composition and strength, 47–54 additional studies of testosterone therapy and, 183–184 clinical trials of testosterone therapy and, 49, 50, 52–54 and endogenous testosterone levels, 48–49 Body mass index (BMI), 39

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Testosterone and Aging: Clinical Research Directions Bone metabolism and density, 41–47, 136–137 additional studies of testosterone therapy and, 182–183 clinical trials of testosterone therapy and, 43, 45, 46, 47 and endogenous testosterone levels, 43–44 Bone mineral density (BMD), 43, 45, 182–183 BOP. See N-nitrosobis(2-oxypropyl)amine BPH. See Benign prostatic hyperplasia Breast Cancer Prevention Trial, 146 Brown-Séquard, Charles, 19 BT. See Bioavailable testosterone Butenandt, Adolf, 19 C CAD. See Coronary artery disease Calcium signaling, 58 Cancer risk factors, as a function of serum prostate specific antigen level and digital rectal examination findings, 140 Carbohydrate metabolism, and cardiovascular risk, 135 Cardiovascular and hematologic outcomes, 73–81 additional studies of testosterone therapy and, 187–189 clinical trials of testosterone therapy and, 79–82 endogenous testosterone levels and, 76, 79 exclusion criteria, monitoring, and follow-up of research participants for, 144–145 Cardiovascular risk factors and lipid and carbohydrate metabolism, 135 and selected studies of endogenous testosterone levels, 77 Central nervous system function, 67–68 CGI. See Clinical Global Impression score Changes in the digital rectal examination, monitoring participants for, 5, 9, 118 in prostate specific antigen levels, monitoring participants for, 5, 9, 118 in testosterone levels, age-related, 6, 9, 118 Cirrhosis, treating with testosterone therapy, 23 Clinical Global Impression score (CGI), 66 Clinical trials of testosterone therapy and body composition and strength, 49, 52–54 and bone-related outcomes, 43, 45, 47 and cardiovascular and hematologic outcomes, 79–81 and cognitive function, 59–61 coordination of, 8 and health-related quality of life, 73 insulin sensitivity measures, 188 lipid profiles, 80, 187–188 and mood and depression, 63, 66 and physical function, 56–58 and prostate outcomes, 92–93 recommendations, 4, 8–9 red blood cell measures, 80 and sexual function, 69, 72 Clinical trials of testosterone therapy in middle-aged men, 7, 161–162 Clinical trials of testosterone therapy in older men, 2–4, 8, 27–28, 117 if short-term efficacy is established, 4, 9, 117 Cognitive function, 3, 58–61, 113, 131–133 additional studies of testosterone therapy and, 184–185 clinical trials of testosterone therapy and, 59–61 endogenous testosterone levels and, 58–59 Concentrations, of estrogen and androgens, 135 Coordination of clinical trials, 8 of initial efficacy trials, 119–120 Coronary artery disease (CAD), 73, 76, 79 CYP17 polymorphisms, 87 Cytokines, 42 D Data sources and methods, 165–172 committee meetings and workshop, 167–172 literature review, 165–167 Dehydroepiandrosterone (DHEA), 13 Dehydroepiandrosterone-sulfate (DHEAS), 13, 76, 121

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Testosterone and Aging: Clinical Research Directions Depression, 61–66, 113 additional studies of testosterone therapy and, 184–185 clinical trials of testosterone therapy and, 63, 64, 66 endogenous testosterone levels and, 62–63 Design issues, 120–125 inclusion criteria, 120–122 measuring testosterone levels, 122–123 sample size, 124–125 testosterone formulation and dose, 123–124 DHEA. See Dehydroepiandrosterone DHEAS. See Dehydroepiandrosterone-sulfate DHT. See Dihydrotestosterone Diabetes exclusion criteria, monitoring, and follow-up of research participants for, 145 and selected studies of endogenous testosterone levels, 77 See also Insulin sensitivity measures Digital rectal examination (DRE), 140 monitoring participants for changes in, 5, 9, 118 Dihydrotestosterone (DHT), 15, 20–21, 86–87, 143 Disability outcomes continuum of diminished, 126 See also Strength, frailty, and disability outcomes Dose, testosterone, 123–124 DRE. See Digital rectal examination Drug abuse, exclusion criteria, monitoring, and follow-up of research participants for, 145 Dual-energy X-ray absorptiometry, 48 Dysthmia, measures of, 137 E E2. See Estradiol ED. See Erectile dysfunction Efficacy, defined, 114n Efficacy and Safety of Testosterone in Elderly Men Trial (ESTEEM), 28, 167 Emphysema, treating with testosterone therapy, 23 Endocrinology, 19 Endogenous testosterone levels, 32 and age, 35 and body composition and strength, 48–49 and bone outcomes, 43, 44 and cardiovascular and hematologic outcomes, 76, 79 and cardiovascular risk factors and diabetes, 77 and cognitive function, 58–59 and mood and depression, 62–63 physiologic regulation of, 6, 9, 118 and prostate outcomes, 89–91 and sexual function, 68–69 Equilibrium dialysis, 18 Erectile dysfunction (ED), 67 ESTEEM. See Efficacy and Safety of Testosterone in Elderly Men Trial Estradiol (E2) concentrations, 14–15, 76, 91 Estrogen concentrations, 121, 135 Ethical issues, 138–145 Exclusion criteria for research participants, 138–145 for men at high risk for developing prostate cancer, 5, 9, 118 for men at high risk for requiring intervention to treat benign prostatic hyperplasia, 5, 9, 118 for prostate outcomes, 139–142 F Family history of prostate cancer, effect on lifetime risk of clinical prostate cancer, 139 Fat distribution, 17 FDA. See Food and Drug Administration Federal Policy for Protection of Human Subjects, 137n Female Sexual Function Index (FSFI), 130 FICSIT. See Frailty and Injuries: Cooperative Studies of Intervention Techniques FIM. See Functional Independence Measure Finasteride, 89 5a-reductase, 20, 87 Follicle stimulating hormone (FSH), 15, 21 Follow-up of research participants, 138–145 for prostate outcomes, 143

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Testosterone and Aging: Clinical Research Directions Food and Drug Administration (FDA), 19, 160 Formulation, of testosterone, 123–124 Frailty. See Strength, frailty, and disability outcomes Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT), 120 Free testosterone (FT), 33, 62 Free testosterone index (FTI), 33 FSFI. See Female Sexual Function Index FSH. See Follicle stimulating hormone FT. See Free testosterone FTI. See Free testosterone index Functional Independence Measure (FIM), 57 Future research directions, 112–158 additional areas of research, 152 initial efficacy trials in older men, 119–137 protection of research participants, 137–149 strategy for future clinical trials in older men, 113–118 G GH. See Growth hormone Ginkgo biloba, 133 Globulin, sex hormone binding, 135 Glucocorticoid therapy, treating pronounced muscle wasting associated with, 22 Gonadotropin-releasing hormone (GnRH), 15, 23, 68 Gonadotropins, 21 Growth, in use of testosterone therapy, 24–27 Growth factor levels, 135 Growth hormone (GH), 13 Gynecomastia, 21 H Hamilton Depression Rating Scale (Ham-D), 66 HDL. See High-density lipoprotein Health outcomes, 32–111, 125–137 body composition and strength, 47–54 bone metabolism and density, 41–47, 136–137 cardiovascular outcomes, 73–81, 135 changes in endogenous testosterone levels with aging, 33–39 cognitive function, 58–61, 131–133 concentration of estrogen and androgens, 135 effects on sex hormone binding globulin, 135 genetic determinants of sex steroid action, 136 growth factor levels, 135 health-related quality of life, 72–73 hematologic outcomes, 73–81, 135 inflammation measures, 135 lipid and carbohydrate metabolism and cardiovascular risk, 135 literature review, 39–41 measures of body composition, 135 measures of dysthmia, 137 mood and depression, 61–66, 137 multiple outcomes, 93–99 physical function, 54–58 potentially adverse, exclusion criteria, monitoring, and follow-up of research participants for, 144–145 prostate outcomes, 81–93 sexual function, 66–72, 128–131 strength, frailty, and disability outcomes, 3, 125–128 well-being, quality of life, and vitality, 3, 133–134 Health-related quality of life (HRQoL), 72–73 additional studies of testosterone therapy and, 186 clinical trials of testosterone therapy and, 73, 74 See also Well-being, quality of life, and vitality Hematocrit, additional studies reporting, 188–189 Hematologic outcomes indices of, 135 and randomized placebo-controlled trials of testosterone therapy in older men, 82 Hemochromatosis, 21 Hemostasis, additional studies reporting, 189

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Testosterone and Aging: Clinical Research Directions Hepatotoxicity, 19 High-density lipoprotein (HDL), 76, 80, 187 HIV. See Human immunodeficiency virus HRQoL. See Health-related quality of life Human immunodeficiency virus (HIV), 73, 184, 186 Hypercapnoeic ventilatory drive, 189–190 Hypogonadism, treating with testosterone therapy, 1, 6, 21–22 I IADL. See Instrumental activities of daily living IIEF. See International Index of Erectile Functioning Implementation issues, 120–125 inclusion criteria, 120–122 measuring testosterone levels, 122–123 sample size, 124–125 testosterone formulation and dose, 123–124 Inclusion criteria, 120–122 Inflammation measures, 135 Initial efficacy trials in older men, 119–137 coordination of initial efficacy trials, 119–120 design and implementation issues, 120–125 primary health outcomes, 125–134 secondary health outcomes, 134–137 Institute of Medicine (IOM), 1, 11, 28, 137–138, 147, 165 Instrumental activities of daily living (IADL), 55 Insulin sensitivity measures, in clinical trials of testosterone therapy, 188 Interim monitoring of trial results and stopping rules, 145–146 incorporation into the trial design, 5, 9, 118 International Index of Erectile Functioning (IIEF), 129–130 IOM. See Institute of Medicine K Klinefelter’s syndrome, 21 L LDL. See Low-density lipoprotein Leydig cell number, 121 LH. See Luteinizing hormone LHRH. See Luteinizing hormone-releasing hormone Libido, 17, 21 Lipid metabolism, and cardiovascular risk, 135 Lipid profiles, in clinical trials of testosterone therapy, 80, 187–188 Literature review, 165–167 LNCaP prostate cancer cells, 88 Longitudinal effects of aging, on date-adjusted testosterone and free testosterone index, 37 Low-density lipoprotein (LDL), 187 Luteinizing hormone (LH), 14–15, 21–23, 68, 121 Luteinizing hormone-releasing hormone (LHRH), 128 M Male breast cancer, exclusion criteria, monitoring, and follow-up of research participants for, 145 Male hair pattern, 17, 21 Male hypogonadism, treating with testosterone therapy, 1, 6, 21–22 Male infertility, 27 Massachusetts Male Aging Study (MMAS), 34, 36, 49, 62, 68, 165 Mechanism of action, of testosterone, 6, 9, 118 Medical conditions treated, 21–23 cirrhosis, 23 emphysema, 23 hypogonadism, 21–22 pronounced muscle wasting associated with glucocorticoid therapy, 22 wasting syndrome of advanced AIDS, 22 Middle-aged men clinical trials of testosterone therapy in, 161–162 randomized placebo-controlled studies of testosterone therapy in, 174

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Testosterone and Aging: Clinical Research Directions Mini-Mental State Examination, 132, 134 MMAS. See Massachusetts Male Aging Study MNU. See N-methyl-N-nitrosourea Monitoring of research participants for adverse effects, 5, 9, 118, 138–145 changes in prostate specific antigen levels, 5, 9, 118 changes in the digital rectal examination, 5, 9, 118 prostate outcomes, 142–143 Mood, 61–66 additional studies of testosterone therapy and, 184–185 clinical trials of testosterone therapy and, 63, 64, 66 endogenous testosterone levels and, 62–63 measures of, 137 MRFIT. See Multiple Risk Factor Intervention Trial Multiple Risk Factor Intervention Trial (MRFIT), 34, 38–39, 79 Muscle mass, maintaining, 17 Muscle wasting associated with glucocorticoid therapy, pronounced, treating with testosterone therapy, 22 Muscle weakness, 113 N N-methyl-N-nitrosourea (MNU), 86 N-nitrosobis(2-oxypropyl)amine (BOP), 86 National Cancer Institute (NCI), 1, 11, 28, 167 National Heart, Lung, and Blood Institute, 27 National Institute for Nursing Research, 120 National Institute on Aging (NIA), 1, 8, 11, 28, 120, 150, 167 National Institutes of Health (NIH), 1, 11, 27, 120, 167 National Research Council, 148, 165 Public Access Records Office, 168 NCI. See National Cancer Institute Needle biopsies, 54 NIA. See National Institute on Aging NIH. See National Institutes of Health O Obesity, exclusion criteria, monitoring, and follow-up of research participants for, 145 Occult prostate carcinoma, 139 Older men need for efficacy studies in, 159–161 randomized placebo-controlled trials of testosterone therapy in, 173–181 recommendations regarding clinical trials of testosterone therapy in, 4, 8–9 Osteopenia, 21, 113 Osteoporosis, 42, 113, 136 P Partner Encounter Profile, 130 Partner Questionnaire, 130 PCPT. See Prostate Cancer Prevention Trial Physical function, 54–58 additional studies of testosterone therapy and, 186 clinical trials of testosterone therapy and, 56–58 in community-dwelling American men, 70 years and older, 55 continuum of diminished, 126 See also Strength, frailty, and disability outcomes Physician’s Health Study, 34, 91 Physiologic regulation, of endogenous testosterone levels, 6, 9, 118 PIN. See Prostate intraepithelial neoplasia Plasma testosterone. See Testosterone PLESS. See Proscar Long-term Efficacy and Safety Study Polycythemia, exclusion criteria, monitoring, and follow-up of research participants for, 144 Potency, 17 Primary health outcomes, 8, 125–134 Proscar Long-term Efficacy and Safety Study (PLESS), 141, 143 Prostate cancer, 86–88, 121, 138 family history of, 139 follow-up, 143 monitoring, 142-–143 occult, 139

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Testosterone and Aging: Clinical Research Directions Prostate Cancer Prevention Trial (PCPT), 89, 143 Prostate intraepithelial neoplasia (PIN), 86 Prostate outcomes, 81–93 additional studies of testosterone therapy and, 189 clinical trials of testosterone therapy and, 92–94 endogenous testosterone levels and, 89–91 exclusion criteria, monitoring, and follow-up of research participants for, 138–143 Prostate-specific antigen (PSA) levels, 5–6, 9, 92, 140–143, 147, 151 monitoring participants for changes in, 5, 9, 118 thresholds based on age and race, 141 Protection of research participants, 5–6, 9, 137–149 exclusion criteria, monitoring, and follow-up, 138–145 interim monitoring of trial results and stopping rules, 145–146 recommendations, 5–6, 118 risk/benefit communication and consent, 146–149 safety and ethical issues, 138–145 PSA. See Prostate-specific antigen levels Psychiatric illness and aggression, exclusion criteria, monitoring, and follow-up of research participants for serious, 145 Q Quality of life. See Health-related quality of life R Radioimmunoassay, 18 Rancho Bernardo study, 34, 39–40, 43, 58, 79 Randomized placebo-controlled studies of testosterone therapy in middle-aged men, 174 Randomized placebo-controlled trials of testosterone therapy in older men, 1, 173–181 and body composition and strength, 50 and bone outcomes, 46 and cardiovascular or hematologic outcomes, 82 and cognitive function, 60 and mood and depression, 64 and multiple outcome measures, 98 and physical function, 56 and prostate outcomes, 94 and quality of life in, 74 and sexual function, 70 Recommendations for further research, 6, 9, 118 age-related changes in testosterone levels, 6, 9, 118 mechanism of action of testosterone, 6, 9, 118 physiologic regulation of endogenous testosterone levels, 6, 9, 118 Recommendations for protection of research participants, 5–6, 118 communicating risks and benefits to study participants, 6, 9, 118 excluding men at high risk for developing prostate cancer, 5, 9, 118 excluding men at high risk for requiring intervention to treat benign prostatic hyperplasia, 5, 9, 118 incorporating interim monitoring findings into the trial design, 5, 9, 118 monitoring participants for any adverse effects, 5, 9, 118 planning carefully to address prostate risk issues, 6, 9, 118 Recommendations regarding clinical trials of testosterone therapy in older men, 4, 8–9, 116–118, 150 beginning with short-term efficacy trials to determine benefit, 4, 8, 117 conducting longer-term studies if short-term efficacy is established, 4, 9, 117 Red blood cell measures, 80 additional studies reporting hematocrit, 188–189 additional studies reporting hemostasis, 189 in clinical trials of testosterone therapy, 80 Regulation physiologic, of endogenous testosterone levels, 6, 9, 118 of testosterone and sperm production by LH and FSH, 16

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Testosterone and Aging: Clinical Research Directions Research issues, 6, 9, 118 age-related changes in testosterone levels, 6, 9, 118 mechanism of action of testosterone, 6, 9, 118 physiologic regulation of endogenous testosterone levels, 6, 9, 118 Research participants, exclusion criteria, monitoring, and follow-up of, 138–145 Research Triangle Institute (RTI), 166–167 Risks communicating to study participants, 6, 9, 118, 146–149 See also Cancer risk factors; Cardiovascular risk factors Rochester Epidemiology Project, 34 RTI. See Research Triangle Institute Ruzicka, Leopold, 19 S Safety issues, 138–145 Sample size, 124–125 Sarcopenia, 54, 126 SARMs. See Selective androgen receptor modulators Secondary health outcomes, 134–137 Selective androgen receptor modulators (SARMs), 7, 20–21, 162 Serotonin, 58 Sertoli cells, 15 Sex hormone-binding globulin (SHBG), 18, 22, 33, 91, 122–123, 135 Sex steroid action, genetic determinants of, 136 Sexual Experience Profile, 130 Sexual function, 3, 66–72, 113, 128–131 additional studies of testosterone therapy and, 185–186 clinical trials of testosterone therapy and, 69, 70, 72 endogenous testosterone levels and, 68–69 SF-36. See Short Form 36 item questionnaire SHBG. See Sex hormone-binding globulin Short Form 36 item questionnaire (SF-36), 58, 73, 134 Short-term efficacy trials to determine benefit, 4, 8, 117 coordination of clinical trials, 8 primary outcomes, 8 study population for initial trials, 8 testosterone preparation and dosages, 8 Sleep apnea, 93, 189 exclusion criteria, monitoring, and follow-up of research participants for uncontrolled, 189–190 Somatopause, 13 Spermatogenesis, 15, 17 Starling, Ernest Henry, 19 Strength, frailty, and disability outcomes, 3, 21, 113, 125–128 Study population, for initial trials, 8 T TC. See Testosterone cypionate TE. See Testosterone enanthate Testosterone, 17 albumin-bound, 16–17 bioavailable, 16, 18 formulation and dose, 123–124 and human development, and health, 14–17 mechanism of action of, 6, 9, 118 partitions in the serum, 17 preparation and dosages, 8, 150 synthesis pathways in human testis, 15 using as a therapeutic intervention, not a preventive measure, 115 Testosterone and health outcomes, 32–111 body composition and strength, 47–54 bone, 41–47 cardiovascular and hematologic outcomes, 73–81 changes in endogenous testosterone levels with aging, 33–39 cognitive function, 58–61 health-related quality of life, 72–73 literature review, 39–41 mood and depression, 61–66 multiple outcomes, 93–99 other health outcomes, 93 physical function, 54–58 prostate outcomes, 81–93 sexual function, 66–72 Testosterone cypionate (TC), 19 Testosterone enanthate (TE), 19 Testosterone levels age-related changes in, 6, 9, 17, 118 in clinical studies, 198–201

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Testosterone and Aging: Clinical Research Directions endogenous, physiologic regulation of, 6, 9, 118 measuring, 122–123 Testosterone therapy, 18–24 additional studies of, 182–197 administering, 19 and body composition and strength, 183–184 and bone, 182–183 and cardiovascular and hematologic outcomes, 187–189 categorization of studies on, 166 and cognitive function, 184–185 and health-related quality of life, 186 and mood and depression, 184–185 and physical function, 186 prescription trend, 25 and prostate outcomes, 189 and sexual function, 185–186 treating medical conditions with, 21–23 use in aging men, 23–24 TF. See Total testosterone Thromboembolic disease, exclusion criteria, monitoring, and follow-up of research participants for, 144–145 Total testosterone (TF), 121 True andropause, 13 U Uncontrolled sleep apnea, exclusion criteria, monitoring, and follow-up of research participants for, 189–190 V Ventilatory drive, hypercapnoeic, 189–190 Vitality. See Well-being, quality of life, and vitality Vitamin D deficiency, 14 W Wasting syndrome of advanced AIDS, treating with testosterone therapy, 22 Weakness. See Strength, frailty, and disability outcomes Well-being, quality of life, and vitality, 3, 113, 133–134 WHI. See Women’s Health Initiative Women’s Health Initiative (WHI), 11, 13, 27, 146, 160 Workshop, 12, 167–172 X X-ray absorptiometry, dual-energy, 48

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