Common use of Inclusion Criteria Clause in Contracts

Inclusion Criteria. Otherwise healthy ambulatory postmenopausal (> 5 years) women from 50 to 85 years of age (inclusive) who meet the study entry criteria and have provided written informed consent are eligible for the study. The women are to have a 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. All patients are to be in good general health as determined by medical history, physical examination (including ▇▇▇▇▇ ▇▇▇▇▇) and clinical laboratory testing. Serum calcium, PTH(1-84), serum phosphorus and serum alkaline phosphatase values must be within the normal range during the Screening Period. Serum 25-hydroxy Vitamin D must be above 15 ng/mL and within 3 times the upper normal range to be eligible for enrollment. The resting 12-lead ECG obtained during screening should have no clinically significant abnormality and a QTc (Bazett’s correction) of < 470 msec. Patients with more than four mild or moderate fractures, or any severe fractures, will be excluded from the study. In addition, patients with fewer than 2 evaluable lumbar vertebrae or patients with unevaluable hip BMD will be excluded from the study. Patients with unexplained elevation of serum alkaline phosphatase, with a history of Paget’s disease, of any cancer within the past 5 years other than basal cell or squamous cancer of the skin, will be ineligible for enrollment. Also, patients with a history of ▇▇▇▇▇▇▇’▇ disease, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year are also ineligible for enrollment. Patients who have ever received treatment with a PTH or PTHrP drug will be excluded. Treatment with bisphosphonates, fluoride or strontium in the past 5 years, or treatment with androgens, other anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months will also exclude patients from enrollment. Patients who had a short course of bisphosphonate treatment (3 months or less) and were intolerant of the treatment may be considered for study participation. Estrogens administered as hormone replacement therapy (HRT), with or without progestins, are not exclusionary. Patients who have participated in a clinical study of any novel unapproved medication in the past 12 months will also be excluded from participation. The specific inclusion and exclusion criteria are described in Sections 4.2 and 4.3 of the protocol, respectively. · Study Design and Methodology: