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Clinical Trials/jRCT1051210070
jRCT1051210070RecruitingNot Applicable

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

Osaka University Hospital0 sites20 target enrollmentStarted: December 24, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Primary Endpoint
Change in bone mineral density of the lumbar spine
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20age old over to No limit (—)
Sex
Female

Inclusion 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:
  • •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.
  • •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.

Exclusion 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.

Outcomes

Primary Outcomes

Change in bone mineral density of the lumbar spine

Time Frame: 6 or 12 months

To evaluate the efficacy of the study drug based on the **amount (and rate) of change** in bone mineral density of the lumbar spine 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.

Change in bone mineral density of the femur

Time Frame: 6 or 12 months

To evaluate the efficacy of the study drug based on the **amount (and rate) of change** in bone mineral density of the 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 Outcomes

  • correlation with bone mineral density assessment
  • bone metabolism markers (P1NP and sCTX)(6 or 12 months)

Investigators

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