Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Brief Summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.


Options:
A: Inclusion Criteria:

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

* BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

  * at least 1 moderate (semiquantitative grade \[SQ\]2) or severe (SQ3) vertebral fracture OR
  * at least 2 mild (SQ1) vertebral fractures OR
* BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

  * at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
  * a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion Criteria:

* History of metabolic or bone disease (except osteoporosis)
* Use of agents affecting bone metabolism
* Vitamin D insufficiency
* History of solid organ or bone marrow transplants
* Hyper- or hypocalcemia
* Hyper- or hypothyroidism
* Hyper- or hypoparathyroidism
* Possible signs of intolerance to alendronate
B: 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
C: Inclusion Criteria:

* Postmenopausal women with established coronary heart disease or at risk for a major coronary event.

Exclusion Criteria:

* Postmenopausal symptoms that required estrogen replacement therapy.
* Suspected or known history of breast or endometrial carcinoma.
* Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis.
* New York Heart Association classes III or IV heart failure.
D: Inclusion Criteria:

* receive maintenance peritoneal dialysis for more than 3 months
* have high calcium-phosphate product (\>55 (mg/dL)2)
* have chest X-ray proven aortic calcification or coronary artery calcification proven by coronary angiography

Exclusion Criteria:

* had been hospitalized in recent 3 months due to severe comorbid disease
* hypersensitive to alendronate or any of its components
* have esophageal disease
* not able to stand or sit upright for 30 minutes
* have refractory hypocalcemia
* being pregnant

Answer: A