Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
|ClinicalTrials.gov Identifier: NCT02049866|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2014
Last Update Posted : March 29, 2019
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).
The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.
Funding Source: FDA Office of Orphan Products Development (OOPD).
|Condition or disease||Intervention/treatment||Phase|
|Adult Idiopathic Generalized Osteoporosis||Drug: Denosumab||Phase 2|
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.
Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)|
|Actual Study Start Date :||November 19, 2014|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2022|
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
- Percent change in lumbar spine areal BMD by DXA [ Time Frame: Baseline and 12 months ]Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049866
|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|
|Principal Investigator:||Adi Cohen, MD||Columbia University|