Health TrialsbyHealthPanel

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

ConditionsOsteoporosisOsteoporosis Postmenopausal
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age50-90
SponsorNational Taiwan University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Romosozumab followed by Denosumab

    Drug

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

  • Romosozumab and Denosumab Cycle Therapy

    Drug

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Sequential therapy groupActive comparator 1 intervention
Group B: Cycle therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in bone mineral density (BMD)

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

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

Secondary outcomes

1

Change in bone turnover makers (BTM) level

Changes in BTM, including bone formation (P1NP) and resorption markers (CTX)

Time frame
Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 13, 15, 18, 21, and 24 months.
2

Change in visual Analogue Scale (VAS) score

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.

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

Oswestry Disability Index (ODI) score change

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.

Time frame
Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
4

New fracture

Any new fracture within 24 months

Time frame
During the intervention period, up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now