Osteoporosis
Conditions
Keywords
Osteoporosis, denosumab, alendronate, zoledronic acid
Brief summary
This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.
Detailed description
This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.
Interventions
DRUGzoledronate
On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
DRUGAlendronate and Zoledronate
Alendronate and Zoledronate: Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose).
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Postmenopausal women or men over 50 years old 2. Continuous Denosumab treatment for at least three years (up to six doses).
Exclusion criteria
1. Secondary osteoporosis 2. Metabolic bone diseases 3. Active or prior malignancy 4. Ongoing systemic glucocorticoid therapy 5. Current use of hormone replacement therapy 6. Current use of any medication known to affect bone metabolism 7. Prior use of any osteoporosis medication other than denosumab 8. Estimated glomerular filtration rate (eGFR) \< 40 mL/min 9. Known hypersensitivity to zoledronic acid 10. Hypocalcemia 11. Any other contraindication to zoledronic acid 12. Age \> 85 years 13. Esophageal abnormalities that delay esophageal emptying (e.g., esophageal stricture, achalasia) 14. Inability to stand or sit upright for at least 30 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density of lumbar spine | one year | Bone mineral density of lumbar spine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density of femoral neck | one year | Bone mineral density of femoral neck |
| Bone mineral density of total hip | one year | Bone mineral density of total hip |
| bone turnover markers | 13 months | Changes of C-terminal telopeptide of type I collagen (CTX) and propeptide of procollagen type I (P1NP) |
| clinical osteoporotic fracture | 1 year | any incidence of clinical osteoporotic fracture |
Countries
Taiwan
Outcome results
None listed