Idiopathic Osteoporosis Clinical Treatment Trial
Orphan disease in premenopausal women
Purpose and Objective
The objective of this clinical trial is to establish the safety and efficacy of teriparatide in premenopausal women with Idiopathic Osteoporosis IOP in a phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a randomly selected group of patients (10) will receive one year of placebo injections first before starting their two years of treatment. The remainder of subjects (30) will receive active drug only for two years.
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 prior research with premenopausal women with IOP, the investigators have shown that women with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to normal women.
There is currently no FDA approved therapy for IOP in premenopausal women. However, teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis. Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of about 113,000 in the United States, pharmaceutical companies are unlikely to support development of therapies for this indication.
Clinical Trial Sponsor
This clinical trial is sponsored by Creighton University.
Recruiting Locations (United States)
Omaha, Nebraska, United States, 68131
Principal Investigator: Robert Recker, MD
Sub-Investigator: Joan Lappe, MD
Columbia University Medical Center
New York, New York, United States, 10032
Principal Investigator: Elizabeth Shane, MD
Sub-Investigator: Adi Cohen, MD
Sub-Investigator: Emily M Stein, MD
Eligibility, Inclusion and Exclusion 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.
- 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 GCs, anticonvulsants, anticoagulants, methotrexate, depot progesterone, 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.
* Additional inclusion/exclusion criteria apply. Please consult with your physician to review the complete eligibility criteria.