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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02049866 (opens ClinicalTrials.gov in a new tab)Other idAAAN0161Other id1R01FD005114-01A2
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Teriparatide (PTH 1-34), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 2
Enrollment
33 participants (actual)
Sponsor
Elizabeth Shane · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
19 Nov 2014
Primary completion
31 Mar 2020
Completion
23 Dec 2021
First posted
30 Jan 2014 (estimated)
Last update posted
12 Dec 2022
Conditions
Adult Idiopathic Generalized Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 2

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

    NCT02049866

    19 Nov 2014 to 23 Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • DenosumabDrug

Arms1

  • Experimental

    Denosumab

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Lumbar Spine Areal BMD by DXA

    Time frame · Baseline and 12 months

    Registry description

    Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

Secondary outcomes(1)

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

    Time frame · Baseline and 24 months

    Registry description

    Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 12 months

Percent Change in Lumbar Spine Areal BMD by DXA

GroupValue (percentage of change)Spread
Denosumab5.22.6
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline and 24 months

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

GroupValue (percentage of change)Spread
Denosumab6.92.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DenosumabDenosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months0 / 330 / 3326 / 33

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2022

9 results

Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis.

Shane et al. 2022The Journal of clinical endocrinology and metabolismcited by 37

PMID 34849989PMC9122662DOI 10.1210/clinem/dgab850PUB-34849989

Rights unknown9 results
Source linkSee results (9)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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