Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Inclusion Criteria

• Premenopausal women of all races.
• Ages 20 to 48.
• Regular menses (at least 8 periods in the last 12 months).
• FSH = 18 (e.g., fracture associated with a fall from a standing height or less).
• Low BMD subjects: DXA BMD T score less than or equal to 2.5 at the LS, total hip, femoral neck or distal radius, who have not had a fracture.
• Control subjects: DXA BMD T score greater than or equal to 1.0 at the LS, total hip, femoral neck and distal radius, who have not had a fracture.
• All subjects must use appropriate birth control methods to prevent pregnancy for the duration of teriparatide treatment.

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 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.