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

Not Applicable

Recruiting

• Conditions: Primary osteoporosis; osteoporosis; D010024

• Registration Number: JPRN-jRCT1041190081
• Lead Sponsor: Asai Shuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone density change (lumbar spine)

Secondary Outcome Measures

Name	Time	Method
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