Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
Status:
Completed
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
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 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. Additionally, using noninvasive high resolution imaging of the central and
peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the
investigators identified several features of bone quality in premenopausal women with IOP.
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. Therefore, the major objective of this protocol
is to establish the safety and efficacy of teriparatide in premenopausal women with 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.
Funding Source - FDA OOPD
Phase:
Phase 2
Details
Lead Sponsor:
Elizabeth Shane
Collaborators:
Creighton University Food and Drug Administration (FDA)