NCT06938152

Brief Summary

This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
45mo left

Started Apr 2025

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress23%
Apr 2025Dec 2029

First Submitted

Initial submission to the registry

April 6, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 19, 2025

Status Verified

April 1, 2025

Enrollment Period

4.1 years

First QC Date

April 6, 2025

Last Update Submit

December 12, 2025

Conditions

OsteoporosisOsteoporosis Postmenopausal

Keywords

postmenopausalRomosozumabDenosumabcycle therapyBone mineral densityBone turnover marker

Outcome Measures

Primary Outcomes (1)

  • Change in bone mineral density (BMD)

    Change in BMD at lumbar spine, femoral neck and total hip at 24 months

    Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.

Secondary Outcomes (5)

  • Change in bone turnover makers (BTM) level

    Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 13, 15, 18, 21, and 24 months.

  • Change in visual Analogue Scale (VAS) score

    Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 15, 18, 21, and 24 months.

  • Oswestry Disability Index (ODI) score change

    Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.

  • New fracture

    During the intervention period, up to 24 months.

  • Adverse Events

    During the intervention period, up to 24 months.

Study Arms (2)

Sequential therapy group

ACTIVE COMPARATOR

Romosozumab followed by Denosumab

Drug: Romosozumab followed by Denosumab

Cycle therapy group

EXPERIMENTAL

Romosozumab and Denosumab Cycle Therapy

Drug: Romosozumab and Denosumab Cycle Therapy

Interventions

Romosozumab followed by DenosumabDRUG

Romosozumab 210mg/month for 12 months, then Denosumab 60mg/6months for 12 months

Also known as: Sequential therapy group
Sequential therapy group
Romosozumab and Denosumab Cycle TherapyDRUG

Romosozumab 210mg/month for 6 months then followed by Denosumab 60mg/6months once, and then repeat one more time after 6 months

Also known as: Cycle therapy group
Cycle therapy group

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Postmenopausal women aged 50-90 years
  • \. BMD T-score ≤ -3.0 at any lumbar vertebra
  • \. Physically and mentally capable of understanding and complying with the study protocol and follow-up
  • \. Signed informed consent

You may not qualify if:

  • \. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
  • \. Allergy to Romosozumab or Denosumab
  • \. Secondary osteoporosis
  • \. Autoimmune disease
  • \. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
  • \. Hypercalcemia or hypocalcemia
  • \. Metabolic bone diseases
  • \. Primary or metastatic bone tumors
  • \. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
  • \. Planned dental procedures (e.g., extractions, implants) within the next year
  • \. History of stent placement, myocardial infarction, stroke, or coronary artery disease
  • \. Renal disease (Creatinine \> 1.5 mg/dL) or dialysis patients
  • \. Smoking more than one pack per day (except for those who have quit for over ten years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (12)

  • Kobayakawa T, Miyazaki A, Takahashi J, Nakamura Y. Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy: The prospective VICTOR study. Bone. 2022 Sep;162:116480. doi: 10.1016/j.bone.2022.116480. Epub 2022 Jul 1.

    PMID: 35787482RESULT

  • Hong N, Shin S, Kim H, Cho SJ, Park JA, Rhee Y. Romosozumab following denosumab improves lumbar spine bone mineral density and trabecular bone score greater than denosumab continuation in postmenopausal women. J Bone Miner Res. 2025 Feb 2;40(2):184-192. doi: 10.1093/jbmr/zjae179.

    PMID: 39485918RESULT

  • Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.

    PMID: 27641143RESULT

  • Chandran M. The why and how of sequential and combination therapy in osteoporosis. A review of the current evidence. Arch Endocrinol Metab. 2022 Nov 11;66(5):724-738. doi: 10.20945/2359-3997000000564.

    PMID: 36382762RESULT

  • Gehrke B, Alves Coelho MC, Brasil d'Alva C, Madeira M. Long-term consequences of osteoporosis therapy with bisphosphonates. Arch Endocrinol Metab. 2023 Nov 10;68:e220334. doi: 10.20945/2359-4292-2022-0334.

    PMID: 37948565RESULT

  • McClung MR, Wagman RB, Miller PD, Wang A, Lewiecki EM. Observations following discontinuation of long-term denosumab therapy. Osteoporos Int. 2017 May;28(5):1723-1732. doi: 10.1007/s00198-017-3919-1. Epub 2017 Jan 31.

    PMID: 28144701RESULT

  • Cosman F, Huang S, McDermott M, Cummings SR. Multiple Vertebral Fractures After Denosumab Discontinuation: FREEDOM and FREEDOM Extension Trials Additional Post Hoc Analyses. J Bone Miner Res. 2022 Nov;37(11):2112-2120. doi: 10.1002/jbmr.4705. Epub 2022 Oct 12.

    PMID: 36088628RESULT

  • Reid IR, Billington EO. Drug therapy for osteoporosis in older adults. Lancet. 2022 Mar 12;399(10329):1080-1092. doi: 10.1016/S0140-6736(21)02646-5.

    PMID: 35279261RESULT

  • LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES. The clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022 Oct;33(10):2049-2102. doi: 10.1007/s00198-021-05900-y. Epub 2022 Apr 28.

    PMID: 35478046RESULT

  • Fogelman I, Blake GM. Different approaches to bone densitometry. J Nucl Med. 2000 Dec;41(12):2015-25.

    PMID: 11138687RESULT

  • Wang CY, Wu CH, Chen HM, Lin JW, Hsu CC, Chang YF, Tai TW, Fu SH, Hwang JS. Cost and effectiveness analyses of the anti-osteoporosis medication in patients with hip fracture in Taiwan: A population-based national claims database analysis. J Formos Med Assoc. 2023;122 Suppl 1:S92-S100. doi: 10.1016/j.jfma.2023.07.018. Epub 2023 Aug 11.

    PMID: 37574339RESULT

  • Wang CY, Fu SH, Yang RS, Shen LJ, Wu FL, Hsiao FY. Age- and gender-specific epidemiology, treatment patterns, and economic burden of osteoporosis and associated fracture in Taiwan between 2009 and 2013. Arch Osteoporos. 2017 Oct 25;12(1):92. doi: 10.1007/s11657-017-0385-5.

    PMID: 29067572RESULT

Related Links

MeSH Terms

Conditions

OsteoporosisOsteoporosis, Postmenopausal

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Fon-Yih Tsuang

CONTACT

886-2312-3456k880113a@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 22, 2025

Study Start

April 8, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

December 19, 2025

Record last verified: 2025-04

Locations

TW(1)