Osteoporosis, Osteoporosis Postmenopausal
Conditions
Keywords
postmenopausal, Romosozumab, Denosumab, cycle therapy, Bone mineral density, Bone turnover marker
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.
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.
Interventions
DRUGRomosozumab followed by Denosumab
Romosozumab 210mg/month for 12 months, then Denosumab 60mg/6months for 12 months
DRUGRomosozumab 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
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bone mineral density (BMD) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Changes in BTM, including bone formation (P1NP) and resorption markers (CTX) |
| 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. | 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. |
| Oswestry Disability Index (ODI) score change | 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. |
| New fracture | During the intervention period, up to 24 months. | Any new fracture within 24 months |
| Adverse Events | During the intervention period, up to 24 months. | Any adverse events |
Countries
Taiwan
Contacts
CONTACTFon-Yih Tsuang
Outcome results
None listed