Overview

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Status:
Completed
Trial end date:
2012-01-03
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Columbia University
Collaborator:
Eli Lilly and Company
Treatments:
Teriparatide
Criteria
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 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.

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.