Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
60–85
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score of less than or equal to -2.5 but must never have had any osteoporotic fragility fracture.
Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed osteoporosis (Inclusion Criterion \[1\]), all women must be free of severe or chronically disabling conditions, have a life expectancy of at least 5 years in the opinion of the investigator, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits.
Had their last natural menstrual period at least 2 years before beginning the study.
Are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study.
Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be adequately evaluated for existing vertebral fractures at screening.
Have centrally read total hip, femoral neck or lumbar spine T-score less than or equal to -2.5
You may not be if
Have known current metabolic bone disorders other than low bone mass, such as hyperparathyroidism, renal osteodystrophy, or osteomalacia.
Have known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized patients with a history of carcinoma in situ of the uterus. For other cancers, be disease free and in remission from all other cancers for 5 or more years, except for excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma of the skin.
Have demonstrated or suspected allergy to raloxifene or arzoxifene
Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or between Visit 1 and Visit 2.
Are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy.
Have a history of or suggestion on ultrasound or pelvic examination of a pre-existing gynecologic abnormality that would require further gynecologic treatment (e.g., ovarian cysts, large fibroids, undiagnosed adnexal masses) or of baseline endometrial thickness of \>5 mm.
Have Papanicolaou's tests showing malignant or premalignant findings.
Have active or any past history of thromboembolic events
Have active or any past history of atrial fibrillation.
Have a history of cerebrovascular accident or documented transient ischemic attack at any time in the past.
Have acute or chronic liver disease defined as alanine aminotransaminase (ALT) \>100 U/L, gamma-glutamyl transferase (GGT) \>400 U/L, or late stage cirrhosis without transaminase elevations.
Have impaired kidney function (serum creatinine \>177 micromol/L or \>2.0 mg/dL).
Have vitamin D deficiency prior to enrollment (Visit 2; 25-hydroxyvitamin D less than10 ng/mL or less than 24.9 nmol/L).
Have any known, severe, or untreated malabsorption syndromes.
Have endocrine disorders requiring pharmacologic therapy except for type II diabetes and hypothyroidism. Patients on a stable dose of thyroid replacement therapy during the 6 months preceding randomization (Visit 2) who are clinically euthyroid in the opinion of the investigator may enroll in the trial.
Consume an excess of alcohol or abuse drugs
Represent an unacceptable medical or psychiatric risk for treatment with an investigational drug
Have active or any history of seizure disorder.
Clareo Health | A Study of Arzoxifene to Treat Korean Women With Osteoporosis
