Primary osteoporosis osteoporosis
Conditions
Interventions
arm Romosozumab: romosozumab 210mg s.c. oncemonthly for 12months
arm Denosumab: denosumab 60mg s.c. once every 6months for 12months
all patients: eldecalcitol 0.75microgram p.o. once a day (Dose redu
C557282/D000069448/C547512
Sponsors
Asai Shuji
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Primary osteoporosis 2.Knee osteoarthritis (Grade II or Grade III Kellgren-Lawrence) 3.Written informed consent
Exclusion criteria
Exclusion criteria: 1.Previous bisphosphonate or teriparatide or romosozumab or denosumab use. Strontium use. For other osteoporosis drugs or treatments that affect bone metabolism, a certain wash out period is acceptable. 2.Current or previous steroid use (more than 3months and 5mg) 3.Previous solid organ or bone marrow transplants 4.Previous osteonecrosis of the jaw 5.GFR45mL/min/1.73m2 or less 6.Hypercalcemia or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range 7.Cardiovascular events within 1 year 8.Patients judged to be inappropriate for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density change (lumbar spine) | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee osteophyte area, Bone density(total hip, femoral neck), VAS, Knee JOA score, OKS, FACIT fatigue, SF-36, EQ-5D, BDI-2, Grip strength, Ca, P, Cre, Bone metabolic marker, Intact PTH, Lumbar spine osteophyte and compression fracture, Exacerbation of arthritis, Adverse events | — |
Contacts
Public ContactHironobu Kosugiyama
Nagoya University Hospital
Outcome results
None listed