DRUG
Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Status
Completed
Phase
Phase 2
Enrollment
33
Locations
2
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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).
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 30, 2014
Study start
Nov 19, 2014
Primary completion
Mar 31, 2020
Study completion
Dec 23, 2021
Results posted
Apr 21, 2021
Registry updated
Dec 12, 2022
Outcomes
What the study measures.
Primary outcomes
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).
Secondary outcomes
Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months
Time frame · Baseline and 24 months
Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 50 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Creighton University
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Publications
Results and literature.
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Related PeptideStat pages
Put the record in context.
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