Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Idiopathic Generalized Osteoporosis
Intervention: Denosumab (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Elizabeth Shane Official(s) and/or principal investigator(s):
Elizabeth Shane, MD, Principal Investigator, Affiliation: Columbia University
Adi Cohen, MD, Study Director, Affiliation: Columbia University
Emily M Stein, MD, Study Director, Affiliation: Columbia University
Overall contact:
Mariana Bucovsky, BA, Phone: 212-305-7225, Email: mb3523@columbia.edu
Summary
The purpose of this research study is to evaluate antiresorptive therapy with denosumab
(Prolia) for prevention of bone loss after stopping teriparatide (Forteo) in premenopausal
women with idiopathic osteoporosis.
Clinical Details
Official title: Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis: a Phase IIB Study
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Percent change in lumbar spine areal BMD by DXA
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.
Investigators are currently enrolling 41 premenopausal women with IOP into a new,
randomized, 24-month, FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of
Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women"
(NCT01440803). The follow-up data from our pilot study lead the investigators to conclude
that participants in FD003902 will require antiresorptive treatment to prevent bone loss
after completing TPTD. Denosumab, a potent inhibitor of osteoclast-mediated bone resorption,
leads to continuous gains in both trabecular and cortical 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. The
investigators will test this hypothesis in a 24-month study of denosumab (Prolia®, 60mg SC
every 6 months). As planned enrollment in NCT01440803 is 41 women and some may not choose
to participate, power is too low for a randomized, placebo-controlled design. Therefore, the
investigators plan an open-label, pilot study. 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Female.
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 will no longer be required for entry into this study.
Exclusion Criteria:
- Renal insufficiency or liver disease: Creatinine, AST/ALT above upper limit of normal
- Vitamin D deficiency: 25-OHD<30 ng/mL
- Pregnancy: urine pregnancy test must be negative
Locations and Contacts
Mariana Bucovsky, BA, Phone: 212-305-7225, Email: mb3523@columbia.edu
Creighton University, Omaha, Nebraska 68131, United States; Recruiting
Phone: 402-280-4470
Robert Recker, MD, Principal Investigator
Joan Lappe, MD, Sub-Investigator
Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Phone: 212-305-7225
Elizabeth Shane, MD, Principal Investigator
Adi Cohen, MD, Sub-Investigator
Emily M Stein, MD, Sub-Investigator
Additional Information
Columbia University, Dept of Medicine, Division of Endocrinology website
Starting date: August 2014
Last updated: April 6, 2015
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