Status:
COMPLETED
Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Menopause
Fracture
Eligibility:
FEMALE
20-48 years
Phase:
PHASE2
PHASE3
Brief 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 treat...
Detailed Description
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. In studies of IOP in men, histomorphometric indices of bone...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00697463
Start Date
August 20 2008
End Date
January 3 2012
Last Update
July 26 2018
Active Locations (2)
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1
Creighton University
Omaha, Nebraska, United States, 68131
2
Columbia University Medical Center
New York, New York, United States, 10032