Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Exclusion Criteria

• •Secondary Causes of Osteoporosis.
• •Disorders of mineral metabolism: primary or secondary hyperparathyroidism (serum intact PTH \> 65 pg/ml), vitamin D deficiency (serum 25OHD \< 30 ng/ml), hypercalciuria (\>300 mg/g creatinine), Paget's disease, clinical osteomalacia, osteogenesis imperfecta (OI).
• •Recent pregnancy or lactation (within past year).
• •Prolonged amenorrhea (\> 6 months) during reproductive years (except during pregnancy or lactation).
• •History of anorexia nervosa.
• •Malignancy, except cured basal or squamous cell skin carcinoma.
• •Endocrinopathy: hyperthyroidism (elevated serum thyroxine and/or suppressed TSH), untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma.
• •Renal insufficiency (serum creatinine above upper limit of female normal range).
• •Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity above upper normal limit).
• •Intestinal disorders (celiac disease, pancreatic insufficiency, inflammatory bowel disease).
• •History or current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate.
• •Current use of depot preparations of progesterone or GnRH agonists.
• •Current use of drug therapies for osteoporosis (estrogen preparations other than contraceptives, raloxifene, bisphosphonates, calcitonin, PTH). Subjects who agree to discontinue use of these medications will be eligible to participate 6 months after discontinuing raloxifene or calcitonin, and 12 months after discontinuing bisphosphonates. Total exposure to bisphosphonates must be \< 1 year. Subjects who have taken PTH at any time in the past will not be eligible.
• •Additional contraindications to teriparatide use: Unexplained elevated total or bone specific alkaline phosphatase or prior external beam or implant radiation therapy involving the skeleton.