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 < 20 mIU/ml during the early follicular phase, to exclude women in theperimenopause.

• Fracture subjects: documented low trauma fracture(s) at age >= 18 (e.g., fractureassociated 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 theduration of teriparatide treatment.

Exclusion Criteria:

• Secondary Causes of Osteoporosis.

• Disorders of mineral metabolism: primary or secondary hyperparathyroidism (serumintact PTH > 65 pg/ml), vitamin D deficiency (serum 25OHD < 30 ng/ml), hypercalciuria (>300 mg/g creatinine), Paget's disease, clinical osteomalacia, osteogenesisimperfecta (OI).

• Recent pregnancy or lactation (within past year).

• Prolonged amenorrhea (> 6 months) during reproductive years (except during pregnancyor 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 uppernormal limit).

• Intestinal disorders (celiac disease, pancreatic insufficiency, inflammatory boweldisease).

• 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 thancontraceptives, raloxifene, bisphosphonates, calcitonin, PTH). Subjects who agree todiscontinue use of these medications will be eligible to participate 6 months afterdiscontinuing raloxifene or calcitonin, and 12 months after discontinuingbisphosphonates. Total exposure to bisphosphonates must be < 1 year. Subjects who havetaken PTH at any time in the past will not be eligible.

• Additional contraindications to teriparatide use: Unexplained elevated total or bonespecific alkaline phosphatase or prior external beam or implant radiation therapyinvolving the skeleton.