Evidence map›Paper›PMID 41392041›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2026

Bone density and remodeling after discontinuation of sequential therapy for premenopausal idiopathic osteoporosis.

Adi Cohen, Mafo Kamanda-Kosseh, Ragyie Rawal, Sanchita Agarwal, Jordan Barry, Stephanie Shiau, Ivelisse Colon, Mariana Bucovsky, Joan M Lappe, Elizabeth Shane

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03396315 (Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03396315 phase2completednot on this map

Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis

TypeinterventionalSponsorColumbia UniversityRan2018 to 2023Enrolled24ConditionsIOP, OsteoporosisArmsAlendronate, Zoledronic Acid
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Adi CohenColumbia University Irving Medical Center, New York, NY, USA. ac1044@columbia.edu.ORCID http://orcid.org/0000-0002-0641-5747
Mafo Kamanda-KossehColumbia University Irving Medical Center, New York, NY, USA.
Ragyie RawalColumbia University Irving Medical Center, New York, NY, USA.
Sanchita AgarwalColumbia University Irving Medical Center, New York, NY, USA.
Jordan BarryColumbia University Irving Medical Center, New York, NY, USA.
Stephanie ShiauDepartment of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.
Ivelisse ColonColumbia University Irving Medical Center, New York, NY, USA.
Mariana BucovskyColumbia University Irving Medical Center, New York, NY, USA.
Joan M LappeCreighton University Medical Center, Omaha, NE, USA.
Elizabeth ShaneColumbia University Irving Medical Center, New York, NY, USA.

Funding

Idiopathic Osteoporosis in Premenopausal WomenK24AR052665 · NIAMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI SHANE, ELIZABETH J · 2005 to 2014
$1.8M
IGF-1, bone turnover and response to teriparatide in premenopausal women with IOPR03AR064016 · NIAMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI COHEN, ADI · 2013 to 2015
$244k
Amgen ISS 20177429FDA HHS R01 FD003902FDA HHS R01 FD005114NIAMS NIH HHS K24 AR052665NIAMS NIH HHS R03 AR064016U.S. Food and Drug Administration FD003902U.S. Food and Drug Administration FD005114
6 · The paper itself

Abstract

In premenopausal IOP, BMD gains on teriparatide-denosumab were maintained on bisphosphonate over 1 year. In 19 followed after bisphosphonate, there was a significant bone loss over 6M, leading to retreatment in some. BMD remained significantly above pretreatment baseline. In premenopausal IOP, the optimal duration of bisphosphonate after denosumab requires further study. We have previously reported that sequential teriparatide-denosumab resulted in large BMD increases in premenopausal women with idiopathic osteoporosis (IOP), and that BMD remained stable with bisphosphonate (alendronate or zoledronate) for 1 year after denosumab cessation (Bisphosphonate Extension Study; BES Year 1). To determine the durability of this effect, an observation year (BES Year 2) off therapy was planned.

participants19 women, aged 44 ± 8, with premenopausal IOP. MEASURES: BMD by DXA, serum CTX every 6 months (M).

resultsOn sequential teriparatide-denosumab, BMD increased by 23 ± 9% at the spine and 12 ± 7% at the total hip. In BES Year 1 on bisphosphonate, BMD and CTX did not change significantly at 6M or 12M. From 12-18M of BES Year 2, BMD declined by 4.2 ± 2.5% at the spine and 1.4 ± 2.1% at the total hip (both p < 0.05); other sites remained stable. CTX increased by 218 ± 210 pg/ml (p < 0.05). At 18M, ten participants resumed bisphosphonates because of bone loss or low BMD and nine continued observation. By the end of BES Year 2, spine BMD stabilized in both groups. BMD at the spine and hip was significantly and substantially higher than before beginning teriparatide.

conclusionIn premenopausal women with IOP, sequential therapy with teriparatide-denosumab was associated with large gains in bone mass that were maintained by 1 year of bisphosphonate treatment. There was significant bone loss during the first 6 months after discontinuing bisphosphonates, leading to retreatment in about half the participants. Despite this bone loss, BMD remained significantly above pretreatment levels. In premenopausal women with IOP, the optimal duration of bisphosphonate therapy after denosumab cessation requires further study.

trial registrationClinicalTrials.gov Identifier: NCT03396315.

Indexed as

Bone DensityBone Density Conservation AgentsBone RemodelingOsteoporosisAbsorptiometry, PhotonAdultBiomarkersCollagen Type IDenosumabDrug Administration ScheduleFemaleFemur NeckHip JointHumansLumbar VertebraeMiddle AgedBiomarkersBone Density Conservation AgentsCollagen Type Icollagen type I trimeric cross-linked peptideDenosumabPeptidesTeriparatideAlendronateBisphosphonateBone densityBone turnover markersDenosumabDenosumab cessationPremenopausal osteoporosisTeriparatideZoledronic acid

Identifiers

PMID41392041
PMCPMC12847150

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.