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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

Page last updated: August 23, 2015

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