NCT02049866

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

November 19, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

December 12, 2022

Status Verified

October 1, 2022

Enrollment Period

5.4 years

First QC Date

January 28, 2014

Results QC Date

March 30, 2021

Last Update Submit

November 15, 2022

Conditions

Adult Idiopathic Generalized Osteoporosis

Keywords

osteoporosispremenopausaldenosumabidiopathicIdiopathic Osteoporosis in Premenopausal Women

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months

    Baseline and 24 months

Study Arms (1)

Denosumab

EXPERIMENTAL

Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.

Drug: Denosumab

Interventions

DenosumabDRUG

Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months

Also known as: Prolia, Xgeva
Denosumab

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 34849989DERIVED

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Mariana Bucovsky
Organization
Columbia University
mb3523@cumc.columbia.edu
212-305-7225

Study Officials

  • Elizabeth Shane, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Adi Cohen, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

November 19, 2014

Primary Completion

March 31, 2020

Study Completion

December 23, 2021

Last Updated

December 12, 2022

Results First Posted

April 21, 2021

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)