Status:
COMPLETED
Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
Lead Sponsor:
Elizabeth Shane
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Adult Idiopathic Generalized Osteoporosis
Eligibility:
FEMALE
20-45 years
Phase:
PHASE2
Brief Summary
Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with no secondary cause of bone loss. In the course of our prior research with pre...
Detailed Description
Osteoporosis is a skeletal disorder characterized by reduced bone strength that predisposes to an increased risk of fracture. Osteoporosis affects postmenopausal women and elderly men and is very unus...
Eligibility Criteria
Inclusion
- Premenopausal women, aged 20-45, with regular menses and no historical or biochemical secondary cause of osteoporosis.
- Documented adult fractures judged to be low-trauma.
- Must be willing to use effective contraception throughout the period of study drug administration.
- Inclusion Criteria - vary slightly based on age category:
- Premenopausal women ages 20-35 years must have at least one major osteoporotic fracture (excluding fractures of fingers, toes and face) and low Bone Mineral Density (BMD).
- Premenopausal women above the age of 35 years should have a history of fracture and/or low BMD.
Exclusion
- History of any condition that increases the risk of osteosarcoma
- Early follicular phase serum
- Disorders of mineral metabolism
- Suspicion of osteomalacia
- Vitamin D deficiency
- Pregnancy or lactation within past 12 months
- Prolonged amenorrhea (\> 6 months) during reproductive years (except pregnancy or lactation)
- Prior eating disorder
- Malignancy, except cured basal or squamous cell skin carcinoma
- Endocrinopathy: new onset untreated hyperthyroidism, hypothyroidism, Cushing's syndrome, prolactinoma
- Renal insufficiency
- Liver disease
- Intestinal disorders
- History/current glucocorticoids (GCs), anticonvulsants, anticoagulants, methotrexate, depot progesterone, Gonadotrophin-releasing hormone (GnRH) agonists
- Oral glucocorticoid use (subject will not be excluded if used dose equivalent to less than prednisone 5 mg for \<3 months).
- Current anticoagulant use or low molecular weight
- Depo Provera use (subjects will not be excluded if used at age\>20, \>5 years ago)
- Drugs for osteoporosis (raloxifene, bisphosphonates, denosumab, calcitonin, TPTD). Subjects who discontinue these medications will be eligible 3 months after stopping raloxifene or calcitonin, 12 months after stopping alendronate, risedronate, ibandronate, or pamidronate and 18 months after stopping denosumab. Subjects with prior use of zoledronate may be eligible if received only one dose \>4 years ago. Total bisphosphonate exposure must be \< 1 year. Subjects who have taken TPTD in the past will not be eligible unless used for \<3 months, \> 2 years ago.
Key Trial Info
Start Date :
August 2 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01440803
Start Date
August 2 2012
End Date
February 1 2019
Last Update
December 11 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Creighton University
Omaha, Nebraska, United States, 68131
2
Columbia University Medical Center
New York, New York, United States, 10032