Bone Mineral Density, Osteoporosis
Conditions
Keywords
Osteoporosis, denosumab, zoledronic acid
Brief summary
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
Detailed description
This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.
Interventions
DRUGContinuous Denosumab
Active comparator: persistent treatment of denosumab.
DRUGAdminister zoledronate and denosumab on an alternating schedule
In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two parallel group would be selected. One group of participants keep their denosumab treatment for 7 years. Another group of participants accept two cycles of treatment (one year of zoledronate and two years of denosumab) and complete with one year of zoledronate.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures. 2. Denosumab treatment for at least two years and less than three years (up to maximum of five doses).
Exclusion criteria
1. Secondary osteoporosis. 2. Metabolic bone diseases. 3. Malignancy. 4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism. 5. Patients had ever used antiosteoporosis medications other than Dmab 6. Estimated glomerular filtration rate \< 35 mL/min. 7. Allergy to Zoledronate. 8. Any other contraindications to Zoledronate use. 9. History of diagnosed hypocalcemia. 10. Age greater than 80 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lumbar spine bone mineral density | From enrollment to the end of treatment at 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in femoral neck bone mineral density | From enrollment to the end of treatment at 3 years and 7 years | — |
| Change in lumbar spine bone mineral density | From enrollment to the end of treatment at 7 years | — |
| Change in C-terminal telopeptide of type 1 collagen | From enrollment to the end of treatment at 3 years and 7 years | — |
| Change in total hip bone mineral density | From enrollment to the end of treatment at 3 years and 7 years | — |
| Fractures | 3 & 7 years | Number of Participants with clinical fractures and radiographic vertebral fractures |
| Change in quality of life | From enrollment to the end of treatment at 3 years and 7 years | — |
| Change in Procollagen type 1 N-terminal propeptide | From enrollment to the end of treatment at 3 years and 7 years | — |
Countries
Taiwan
Outcome results
None listed