Total REview of Anti-Sclerostin antibody Use Related to Elderly people (TREASURE) study

JRCT ID: jRCT1041190081

Registered date:19/12/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary osteoporosis
• Date of first enrollment: 24/01/2020
• Target sample size: 120
• Study type: Interventional

Intervention(s)

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 reduced to 0.5microgram once a day depending on symptoms)

Outcome(s)

• Primary Outcome: Bone density change (lumbar spine)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: <= 90age old
• Gender: Female

Include criteria

1.Primary osteoporosis
2.Knee osteoarthritis (Grade II or Grade III Kellgren-Lawrence)
3.Written informed consent

Exclude 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

Related Information

• Primary Sponsor: Asai Shuji
• Source(s) of Monetary Support: Nagoya University Hospital Funding for Clinical Development