Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Completed · Phase 2/Phase 3

Conditions studied: Menopause, Fracture, Osteoporosis

In brief

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide \[PTH(1-34)\], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.

Key facts

Study ID

NCT00697463

Run by

Columbia University

People needed

22

Starts

2008-08-20

Expected to finish

2012-01-03

Last updated by the study team

2018-07-26

Who can join

Age: 20 and older, up to 48. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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 the perimenopause.
• Fracture subjects: documented low trauma fracture(s) at age >= 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.

You may not qualify if…

• 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.

Where it is running

• Creighton University — Omaha, Nebraska, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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