Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients

December 12, 2025 updated by: National Taiwan University Hospital

Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoporosis is common in postmenopausal women and the elderly, and has been recognized by the World Health Organization as the second most prevalent metabolic bone disease worldwide. Most patients show no obvious symptoms, but a fall or sudden exertion can cause fragility fractures. Once fractures occur, complications such as acute pain, prolonged bed rest, and restricted mobility can significantly impact the quality of life and even increase mortality. Furthermore, managing these conditions requires substantial medical and social resources.

Currently, anti-osteoporosis medications are classified into two major categories: antiresorptive and anabolic agents. Studies have confirmed that both types can increase bone mineral density (BMD) and reduce fracture risk. However, each medication has usage limitations.

Denosumab is a potent antiresorptive drug, but long-term use can lead to rare side effects such as atypical femoral fractures (AFF) and medication-related osteonecrosis of the jaw (MRONJ). Additionally, stopping Denosumab can cause a severe rebound in bone resorption markers (CTX), leading to rapid BMD loss and an increased fracture risk. Managing drug discontinuation remains a major clinical challenge.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequential therapy group
Romosozumab followed by Denosumab
Drug: Romosozumab followed by Denosumab
Romosozumab 210mg/month for 12 months, then Denosumab 60mg/6months for 12 months
Other Names:
  • Sequential therapy group
Experimental: Cycle therapy group
Romosozumab and Denosumab Cycle Therapy
Drug: Romosozumab and Denosumab Cycle Therapy
Romosozumab 210mg/month for 6 months then followed by Denosumab 60mg/6months once, and then repeat one more time after 6 months
Other Names:
  • Cycle therapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone mineral density (BMD)
Time Frame: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone turnover makers (BTM) level
Time Frame: Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 13, 15, 18, 21, and 24 months.
Changes in BTM, including bone formation (P1NP) and resorption markers (CTX)
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
Time Frame: Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 15, 18, 21, and 24 months.
The Visual Analogue Scale (VAS) for pain will be used to assess participants' self-reported pain intensity. The VAS score ranges from 0 to 10, higher scores indicate worse pain intensity, and lower scores indicate less pain.
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
Time Frame: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
The Oswestry Disability Index (ODI) will be used to assess the level of disability related to lower back pain. The ODI score ranges from 0 to 100, higher scores reflect worse functional disability and lower scores reflect better functional status.
Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
New fracture
Time Frame: During the intervention period, up to 24 months.
Any new fracture within 24 months
During the intervention period, up to 24 months.
Adverse Events
Time Frame: During the intervention period, up to 24 months.
Any adverse events
During the intervention period, up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202501144MINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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