Prospective observational study of the effect of romosozumab in postmenopausal osteoporotic women with inadequate response to existing osteoporosis treatment

JRCT ID: jRCT1051210070

Registered date:24/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoporosis, Postmenopausal
• Date of first enrollment: 24/12/2019
• Target sample size: 20
• Study type: Observational

Outcome(s)

Primary Outcome

Primary endpoint: To evaluate the efficacy of the study drug based on the amount (and rate) of change in bone mineral density of the lumbar spine and femur after 6 or 12 months of treatment relative to the starting value of the study drug.
Bone densitometry will be performed using the DXA (dual X-ray absorptiometry) method.

• Secondary Outcome: Secondary endpoints: To evaluate the efficacy of the study drug based on the amount (and rate of change) of changes in the bone metabolism markers, type 1 procollagen N-terminal propeptide (P1NP) and serum C-telopeptide cross-link of type 1 collagen (sCTX), after 6 or 12 months of treatment relative to the values at the start of treatment with the study drug, and to examine the correlation with the results of bone mineral density assessment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

Patients with postmenopausal osteoporosis who have been treated with bisphosphonates or denosumab at our department for at least one year, but whose bone mineral density values of lumbar spine or femur by DXA method are less than 70% of YAM (Young Adult Mean) will be included.
Bone mineral density will be measured by measuring the bone mineral density of the lumbar spine and femur by the double X-ray absorptiometry (DXA method) using a bone mineral density measurement device (Discovery A Hologic) installed at our hospital. The diagnosis shall be based on the therapeutic intervention criteria set forth by the Japanese Society of Osteoporosis and shall meet the following diagnostic criteria.
The criteria for the diagnosis of osteoporosis are as follows:
1) For patients with fragility fractures, 1:there must be a vertebral fracture or a proximal femoral fracture 2: There must be other fragility fractures and the bone density must be less than 80% of the YAM.
2) In the absence of a fragility fracture, bone density should be less than 70% of the YAM or less than -2.5 SD.
The cause of osteoporosis is not limited to postmenopausal osteoporosis, but also includes osteoporosis associated with hormone decline after cancer treatment.

Exclude criteria

(1) Patients with a history of hypersensitivity to components of sclerostin products.
(2) Patients with hypocalcemia.
(3) Patients who are judged by the physician in charge to be inappropriate for this study for other reasons.

Related Information

• Primary Sponsor: Yamamoto Misa