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

Study Overview
=================
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).

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.

Official Title
-----------------
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)

Conditions
-----------------
Adult Idiopathic Generalized Osteoporosis

Intervention / Treatment
-----------------
* Drug: Denosumab


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br>Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. | Drug: Denosumab<br>* Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months<br>* Other names: Xgeva;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lumbar Spine Areal BMD by DXA | Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA). | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months | Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA). | Baseline and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, premenopausal, denosumab, idiopathic, Idiopathic Osteoporosis in Premenopausal Women