Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 20 - 50 |
| Updated: | 3/31/2019 |
| Start Date: | November 19, 2014 |
| End Date: | February 28, 2022 |
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)
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).
(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).
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.
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.
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
We found this trial at
2
sites
2500 California Plaza
Omaha, Nebraska 68102
Omaha, Nebraska 68102
(402) 280-2700
Principal Investigator: Robert Recker, MD
Phone: 402-280-4470
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Elizabeth Shane, MD
Phone: 212-305-7225
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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