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Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

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ClinicalTrials.gov Identifier: NCT02049866
Recruitment Status : Active, not recruiting
First Posted : January 30, 2014
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Creighton University
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.
Drug: Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Other Names:
  • Prolia
  • Xgeva




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.
  • (Premenopausal status is no longer be required for entry.)

Exclusion Criteria:

  • Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal
  • Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL
  • Pregnancy: urine pregnancy test must be negative

Information from the National Library of Medicine

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): NCT02049866


Locations
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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Elizabeth Shane
Creighton University
Investigators
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Principal Investigator: Elizabeth Shane, MD Columbia University
Principal Investigator: Adi Cohen, MD Columbia University

Additional Information:
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Responsible Party: Elizabeth Shane, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT02049866     History of Changes
Other Study ID Numbers: AAAN0161
1R01FD005114-01A2 ( U.S. FDA Grant/Contract )
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Shane, Columbia University:
osteoporosis
premenopausal
denosumab
idiopathic
Idiopathic Osteoporosis in Premenopausal Women
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents