Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
NCT ID: NCT02049866
Last Updated: 2022-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2014-11-19
2021-12-23
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.
Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Interventions
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Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (Premenopausal status is no longer be required for entry.)
Exclusion Criteria
* Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) \<30 ng/mL
* Pregnancy: urine pregnancy test must be negative
20 Years
50 Years
FEMALE
No
Sponsors
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Creighton University
OTHER
Elizabeth Shane
OTHER
Responsible Party
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Elizabeth Shane
Professor of Medicine
Principal Investigators
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Elizabeth Shane, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Adi Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Creighton University
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Countries
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References
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Shane E, Shiau S, Recker RR, Lappe JM, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Stubby J, Cohen A. Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1528-e1540. doi: 10.1210/clinem/dgab850.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Columbia University, Dept of Medicine, Division of Endocrinology website
Other Identifiers
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AAAN0161
Identifier Type: -
Identifier Source: org_study_id