Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
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|ClinicalTrials.gov Identifier: NCT01440803|
Recruitment Status : Active, not recruiting
First Posted : September 27, 2011
Last Update Posted : March 5, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Adult Idiopathic Generalized Osteoporosis||Drug: Teriparatide Drug: Saline Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women|
|Actual Study Start Date :||August 2, 2012|
|Actual Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2019|
Active Comparator: Teriparatide (Forteo)
Daily injection of Teriparatide for treatment of idiopathic osteoporosis
Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
Placebo Comparator: Placebo saline injection
Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.
Drug: Saline Placebo
Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.
Other Name: Placebo
- Change in lumbar spine bone mineral density (LS-BMD) [ Time Frame: Baseline and 12 months ]Dual Energy X-ray Absorptiometry (DXA) will be used to measuring bone mineral density (BMD).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440803
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Elizabeth Shane, MD||Columbia University|
|Study Director:||Adi Cohen, MD||Columbia University|
|Study Director:||Emily M Stein, MD||Columbia University|