Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women (NCT01440803) | Clinical Trial Compass
CompletedPhase 2
Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
United States41 participantsStarted 2012-08-02
Plain-language 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
Who can participate
Age range
20 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication