Romosozumab/Denosumab Study for Premenopausal IOP

You may not qualify if:

• Any cardiovascular disease: history of myocardial infarction (MI) or stroke. Normal electrocardiogram (ECG) or ECG with no clinically significant abnormality is required at study entry.
• Conditions requiring chronic anticoagulation (coumadin, heparins)
• Early follicular phase serum FSH\>20 mIU/ml (to exclude perimenopausal women)
• Disorders of mineral metabolism: primary/secondary hyperparathyroidism, osteomalacia (including that associated with a diagnosis of hypophosphatasia), vitamin D deficiency
• Suspicion of osteomalacia (elevated alkaline phosphatase, bone pain exacerbated by weight bearing, bone tenderness)
• Vitamin D deficiency (serum 25-OHD\<30ng/ml). Women with levels of 10-29 ng/ml will be eligible after treatment with vitamin D has resulted in levels ≥30 ng/ml.
• Hypocalcemia
• Current pregnancy or lactation
• Highly effective contraception is required, pregnancy testing is performed at each visit
• Current active eating disorder, hypothalamic or exercise induced amenorrhea. Patients with past history of these disorders, resolved \> 1 year ago, are eligible to participate. The Eating Aptitude Test -Questionnaire is given to identify women with subclinical eating disorders
• Current malignancy
• Endocrinopathy: new onset untreated hyperthyroidism/hypothyroidism, Cushing's syndrome, prolactinoma
• Renal insufficiency (eGFR below 60 ml/min)
• Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity above upper normal limit)
• Intestinal malabsorption disorders including but not limited to pancreatic insufficiency, active Crohn Disease or untreated celiac disease.
• +13 more criteria