Clinical trial NCT02049866: Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Official title: Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Idiopathic Generalized Osteoporosis
Keywords: osteoporosis
premenopausal
denosumab
idiopathic
Idiopathic Osteoporosis in Premenopausal Women
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Creighton University
First posted: 2014-01-30
Enrollment: 33
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percent Change in Lumbar Spine Areal BMD by DXA
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months
timeFrame: Baseline and 24 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Elizabeth Shane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Adi Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shane E, Shiau S, Recker RR, Lappe JM, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Stubby J, Cohen A. Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1528-e1540. doi: 10.1210/clinem/dgab850.