Inclusion and exclusion criteria for study participants in both target population groups (ie, fragility fracture cases and controls).
| Inclusion criteria common across both cases & controls . | Inclusion criteria specific to fragility fracture cases . | Inclusion criteria specific to controls . |
|---|---|---|
| Females | Has experienced a fragility fracture of the arms (including wrist fractures) or legs (including hip or ankle fractures) after the age of 50 yr. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture is operationally defined based on self-report of an arm or leg fracture caused by falls from a height < 6 in. A fragility fracture will not count if it is associated with (1) running, bicycling or other similar fast-moving activity such as sports, (2) being struck by a falling or otherwise quickly moving heavy object, or (3) a motor vehicle accident | Self-reports not experiencing a fracture at any site after the age of 40 yr (does not include fractures of the digits, toes, or face) |
| 50-80 yr of age | ||
| Self-report that their last menses occurred at least 24-mo prior to enrollment | ||
| BMI between 18.5 and 35 kg/m2 | ||
| In the opinion of the site principal investigator the study participant is physically able to safely participate in the study activities | Does not self-report losing >3.8 cm (1.5 in.) in stature in the prior 15 yr | |
| Able to provide informed consent | ||
| Exclusion criteria common across both cases and controls | ||
| Use of systemic glucocorticoids for >6-mo in the prior 1 yr | ||
| Self-reported diseases that could interfere with bone metabolism. For example, osteomalacia, bone cancer, myeloma, Paget’s disease, hyper parathyroidism, hyperthyroidism not treated, severe renal (eg, stage 4+ CKD, history of dialysis, kidney transplant, etc.), hepatic insufficiency, or prolonged immobilization (>2 mo in the previous year) | ||
| Self-reported type 1 diabetes | ||
| Self-reports being told by a physician that they have a terminal illness | ||
| Has had bilateral hip replacements | ||
| The subject will be excluded if they answer yes to the following question: Do you have an active rotator cuff tear, had shoulder surgery in the past 12-mo, or experience severe shoulder, wrist, or elbow joint pain on a regular basis? | ||
| Persons living in a nursing home (those living in assisted living or independent housing will not be excluded) | ||
| Unable to communicate because of severe hearing loss or speech disorder | ||
| If, in the opinion of a site principal investigator, a study participant is inappropriate for the scientific purposes of this study. For instance, a high fall risk patient due to an existing neurological disorder (eg, Parkinson’s disease, Amyotrophic Lateral Sclerosis, etc.) would be excluded | ||
| Failure to provide informed consent | ||
| Inclusion criteria common across both cases & controls . | Inclusion criteria specific to fragility fracture cases . | Inclusion criteria specific to controls . |
|---|---|---|
| Females | Has experienced a fragility fracture of the arms (including wrist fractures) or legs (including hip or ankle fractures) after the age of 50 yr. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture is operationally defined based on self-report of an arm or leg fracture caused by falls from a height < 6 in. A fragility fracture will not count if it is associated with (1) running, bicycling or other similar fast-moving activity such as sports, (2) being struck by a falling or otherwise quickly moving heavy object, or (3) a motor vehicle accident | Self-reports not experiencing a fracture at any site after the age of 40 yr (does not include fractures of the digits, toes, or face) |
| 50-80 yr of age | ||
| Self-report that their last menses occurred at least 24-mo prior to enrollment | ||
| BMI between 18.5 and 35 kg/m2 | ||
| In the opinion of the site principal investigator the study participant is physically able to safely participate in the study activities | Does not self-report losing >3.8 cm (1.5 in.) in stature in the prior 15 yr | |
| Able to provide informed consent | ||
| Exclusion criteria common across both cases and controls | ||
| Use of systemic glucocorticoids for >6-mo in the prior 1 yr | ||
| Self-reported diseases that could interfere with bone metabolism. For example, osteomalacia, bone cancer, myeloma, Paget’s disease, hyper parathyroidism, hyperthyroidism not treated, severe renal (eg, stage 4+ CKD, history of dialysis, kidney transplant, etc.), hepatic insufficiency, or prolonged immobilization (>2 mo in the previous year) | ||
| Self-reported type 1 diabetes | ||
| Self-reports being told by a physician that they have a terminal illness | ||
| Has had bilateral hip replacements | ||
| The subject will be excluded if they answer yes to the following question: Do you have an active rotator cuff tear, had shoulder surgery in the past 12-mo, or experience severe shoulder, wrist, or elbow joint pain on a regular basis? | ||
| Persons living in a nursing home (those living in assisted living or independent housing will not be excluded) | ||
| Unable to communicate because of severe hearing loss or speech disorder | ||
| If, in the opinion of a site principal investigator, a study participant is inappropriate for the scientific purposes of this study. For instance, a high fall risk patient due to an existing neurological disorder (eg, Parkinson’s disease, Amyotrophic Lateral Sclerosis, etc.) would be excluded | ||
| Failure to provide informed consent | ||
Inclusion and exclusion criteria for study participants in both target population groups (ie, fragility fracture cases and controls).
| Inclusion criteria common across both cases & controls . | Inclusion criteria specific to fragility fracture cases . | Inclusion criteria specific to controls . |
|---|---|---|
| Females | Has experienced a fragility fracture of the arms (including wrist fractures) or legs (including hip or ankle fractures) after the age of 50 yr. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture is operationally defined based on self-report of an arm or leg fracture caused by falls from a height < 6 in. A fragility fracture will not count if it is associated with (1) running, bicycling or other similar fast-moving activity such as sports, (2) being struck by a falling or otherwise quickly moving heavy object, or (3) a motor vehicle accident | Self-reports not experiencing a fracture at any site after the age of 40 yr (does not include fractures of the digits, toes, or face) |
| 50-80 yr of age | ||
| Self-report that their last menses occurred at least 24-mo prior to enrollment | ||
| BMI between 18.5 and 35 kg/m2 | ||
| In the opinion of the site principal investigator the study participant is physically able to safely participate in the study activities | Does not self-report losing >3.8 cm (1.5 in.) in stature in the prior 15 yr | |
| Able to provide informed consent | ||
| Exclusion criteria common across both cases and controls | ||
| Use of systemic glucocorticoids for >6-mo in the prior 1 yr | ||
| Self-reported diseases that could interfere with bone metabolism. For example, osteomalacia, bone cancer, myeloma, Paget’s disease, hyper parathyroidism, hyperthyroidism not treated, severe renal (eg, stage 4+ CKD, history of dialysis, kidney transplant, etc.), hepatic insufficiency, or prolonged immobilization (>2 mo in the previous year) | ||
| Self-reported type 1 diabetes | ||
| Self-reports being told by a physician that they have a terminal illness | ||
| Has had bilateral hip replacements | ||
| The subject will be excluded if they answer yes to the following question: Do you have an active rotator cuff tear, had shoulder surgery in the past 12-mo, or experience severe shoulder, wrist, or elbow joint pain on a regular basis? | ||
| Persons living in a nursing home (those living in assisted living or independent housing will not be excluded) | ||
| Unable to communicate because of severe hearing loss or speech disorder | ||
| If, in the opinion of a site principal investigator, a study participant is inappropriate for the scientific purposes of this study. For instance, a high fall risk patient due to an existing neurological disorder (eg, Parkinson’s disease, Amyotrophic Lateral Sclerosis, etc.) would be excluded | ||
| Failure to provide informed consent | ||
| Inclusion criteria common across both cases & controls . | Inclusion criteria specific to fragility fracture cases . | Inclusion criteria specific to controls . |
|---|---|---|
| Females | Has experienced a fragility fracture of the arms (including wrist fractures) or legs (including hip or ankle fractures) after the age of 50 yr. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture is operationally defined based on self-report of an arm or leg fracture caused by falls from a height < 6 in. A fragility fracture will not count if it is associated with (1) running, bicycling or other similar fast-moving activity such as sports, (2) being struck by a falling or otherwise quickly moving heavy object, or (3) a motor vehicle accident | Self-reports not experiencing a fracture at any site after the age of 40 yr (does not include fractures of the digits, toes, or face) |
| 50-80 yr of age | ||
| Self-report that their last menses occurred at least 24-mo prior to enrollment | ||
| BMI between 18.5 and 35 kg/m2 | ||
| In the opinion of the site principal investigator the study participant is physically able to safely participate in the study activities | Does not self-report losing >3.8 cm (1.5 in.) in stature in the prior 15 yr | |
| Able to provide informed consent | ||
| Exclusion criteria common across both cases and controls | ||
| Use of systemic glucocorticoids for >6-mo in the prior 1 yr | ||
| Self-reported diseases that could interfere with bone metabolism. For example, osteomalacia, bone cancer, myeloma, Paget’s disease, hyper parathyroidism, hyperthyroidism not treated, severe renal (eg, stage 4+ CKD, history of dialysis, kidney transplant, etc.), hepatic insufficiency, or prolonged immobilization (>2 mo in the previous year) | ||
| Self-reported type 1 diabetes | ||
| Self-reports being told by a physician that they have a terminal illness | ||
| Has had bilateral hip replacements | ||
| The subject will be excluded if they answer yes to the following question: Do you have an active rotator cuff tear, had shoulder surgery in the past 12-mo, or experience severe shoulder, wrist, or elbow joint pain on a regular basis? | ||
| Persons living in a nursing home (those living in assisted living or independent housing will not be excluded) | ||
| Unable to communicate because of severe hearing loss or speech disorder | ||
| If, in the opinion of a site principal investigator, a study participant is inappropriate for the scientific purposes of this study. For instance, a high fall risk patient due to an existing neurological disorder (eg, Parkinson’s disease, Amyotrophic Lateral Sclerosis, etc.) would be excluded | ||
| Failure to provide informed consent | ||
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