Metabolic bone disease
Conditions
Interventions
Joint Group:Teriparatide 20 µg/day + Denosumab 60 mg every 6 months Subcutaneous injection, for a total of 2 years
Control group:Denosumab 60mg every six months, subcutaneous injection, for a total of 2 years
Sponsors
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 18 years; 2. DXA bone density or QCT bone density at our hospital indicates at least a diagnosis of osteoporosis; 3. Poor past response to bisphosphonate (BPs) treatment, unsatisfactory expected improvement in bone density, or severe condition making BPs unsuitable as initial therapy.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to either of the two drugs or any of their excipients; 2. Patients requiring invasive oral procedures; 3. Patients with severe renal impairment; 4. Patients with hypercalcemia; 5. Patients who are pregnant or breastfeeding; 6. Patients with skeletal metabolic diseases other than primary osteoporosis and glucocorticoid-induced osteoporosis (including hyperparathyroidism and Paget’s disease); 7. Patients with malignant bone tumors or bone metastases; 8. Patients who have previously received external radiation or radioactive bone implants; 9. Patients unable to receive subcutaneous injections; 10. Patients unable to adhere to the dosing schedule (teriparatide is a daily subcutaneous injection; denosumab is a subcutaneous injection every six months. Due to its pharmacokinetic characteristics, denosumab must be administered on schedule every six months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DXA Bone Mineral Density; | — |
Secondary
| Measure | Time frame |
|---|---|
| ß-CTX;P1NP;BALP;PTH;Serum albumin;Serum phosphorus; | — |
Countries
China
Contacts
Public ContactQin Wang
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University
Outcome results
None listed