Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture
Brief Summary: The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.


Options:
A: Inclusion Criteria:

* Aged 21 years or older;
* Chronic maintenance dialysis of at least 3 months' duration;
* Osteoporotic by DXA of either spine or total hip (Women: post-menopausal or age ≥ 50 with T-score ≤ -2.5; Men: age ≥ 50 with T-score ≤ -2.5; All others, Z-score ≤ -2.5);
* Mental competence;
* Willingness to participate in the study;
* Normal serum calcium.

Exclusion Criteria:

* Pregnancy or breast feeding;
* Incarceration;
* Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
* Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
* Chronic alcoholism and/or drug addiction;
* Known Paget 's disease of bone;
* Prior external beam or implant radiation therapy involving the skeleton;
* More than 3 computed tomography (CT) scans in the prior 12 months (to avoid excessive radiation exposure);
* Participation in a study of an investigational drug during the past 90 days;
* Planning to move out of the area within 1 year of the study;
* On active transplant list;
* BMD t-score of the radius less than -3.5 by DXA (to avoid the known potential negative effects of teriparatide treatment on BMD of the radius);
* Planned or anticipated oral surgery within the next 12 months;
* Inability to stand or sit upright for at least 30 minutes;
* Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia;
* Treatment within last 6 months with drugs that may affect bone metabolism including bisphosphonates and teriparatide (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics);
* Current treatment with medicines containing digoxin or warfarin;
* Calcidiol level below the normal range. (The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.)
B: Inclusion Criteria:

* Patient of 65 years or older
* Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
* Patient with osteoporosis (history of bone fracture or T-scoring \< -2.5 SD)
* PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.

Exclusion Criteria:

* Cinacalcet treatment
* Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines
* Suspicion of lower bone remodeling
* Hypersensibility to active substance or one of excipients of denosumab
* Patient with a cancer or myeloma
* Patient with severe heaptic cytolysis
* Patients with severe teeth problems
* Patient positive for HIV
* Patient involved in another biomedical research
* Vulnerable patients (protected by the law, under guardianship, deprived of freedom)
C: Inclusion Criteria:

- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

* BMD T-score of ≤ -3.50 at the total hip or femoral neck
* History of hip fracture
* Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism
D: Inclusion Criteria:

* Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
* The women are to have a bone mineral density (BMD) T score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and \> -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and \> -5.0
* Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
* Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion Criteria:

* History of more than 4 mild or moderate spine fractures or any severe fracture
* Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
* Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
* History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
* Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
* Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
* Prior treatment with an investigational drug within the past 12 months
* History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time

Answer: D