Comparing Denosumab with Eldecalcitol or Vitamin D for Osteoporosis in Postmenopausal Women
Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
This study tests whether the medication denosumab works better than eldecalcitol or vitamin D in helping postmenopausal women with osteoporosis strengthen their bones.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | Female |
| Sponsor | Xi'an Honghui Hospital Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Xi'an) |
| Trial ID | NCT05884372 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of denosumab compared to eldecalcitol and native vitamin D in improving bone mineral density (BMD) in postmenopausal women diagnosed with osteoporosis. The primary focus is on measuring changes in BMD, while secondary objectives include assessing various health markers such as bone turnover, muscle strength, and quality of life. Participants will receive one of the three treatments and undergo regular assessments to monitor their progress. The study seeks to provide insights into the most effective treatment options for this demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women diagnosed with osteoporosis, as indicated by a BMD T value of ≤-2.5.
Not a fit: Patients with secondary osteoporosis due to conditions like hyperthyroidism or those who have previously received denosumab therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for postmenopausal women with osteoporosis, enhancing their bone health and overall quality of life.
How similar studies have performed: Previous studies have shown varying degrees of success with similar treatments for osteoporosis, but this specific comparison of denosumab with eldecalcitol and vitamin D is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5. * 2.Voluntarily participate in this study and sign the informed consent. Exclusion Criteria: * 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin \[HbA1c\>7.5%\]), or other diseases that may lead to secondary osteoporosis. * 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, glucocorticoids, calcitonin, vitamin K, active vitamin D, gonadotropin-releasing hormone agonists, isotopes Flavonoids, selective estrogen receptor modulators, or hormone replacement therapy. * 3.Patients with urolithiasis revealed by B-ultrasound at screening. * 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (\> 0.4 mg/dL GF), or chronic kidney disease (eGFR \< 30 mL/min/1.73 m2). * 5.Patients with malignant tumors or patients with a history of malignant tumors within the previous 3 years. * 6.Patients judged by investigators to be unsuitable as subjects.
Where this trial is running
Xi'an
- Zeng,Yuhong — Xi'an, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.