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NCT02049866COMPLETEDanonymous

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

Sponsor

Source record

Elizabeth Shane

Phase

Source record

PHASE2

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab

Indication / condition

AI-normalized

Adult Idiopathic Generalized Osteoporosis

Intervention

Source record

Denosumab

Source & freshness

Source record

NCT ID

NCT02049866

Original source

ClinicalTrials.gov

Source last updated

Dec 12, 2022

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT02049866

Title

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

Sponsor

Elizabeth Shane

Status

COMPLETED

Phase

PHASE2

Condition raw

Adult Idiopathic Generalized Osteoporosis

Condition normalized

Adult Idiopathic Generalized Osteoporosis

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Denosumab

Target normalized

Denosumab

Interventions

Denosumab

Public preview

Source record

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).

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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