Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT01440803
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01440803
Study Brief:
Protocol Section:
NCT01440803