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The efficacy and safety of teriparatide in advanced chronic kidney disease

Recruiting
Conditions
Osteoporosis, osteopenia
Registration Number
jRCTs041240136
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
35
Inclusion Criteria

Patients with chronic kidney disease stage 4 and 5 and meeting one of the following criteria

  1. Meeting criteria for the diagnosis of osteoporosis
  2. Trabecular bone score less than -2.0 and T score of bone mineral density more than -2.5 and less than -1.0
Exclusion Criteria
  1. Those on maintenance dialysis or expecting the initiation of dialysis within 2 years
  2. Those who had kidney transplantation
  3. Those on corticosteroid treatment, i.e. prednisolone equivalent dose more than 5mg a day
  4. Intact PTH 150 pg/mL and over
  5. Bone Paget disease
  6. Alkaline phosphatase twice the upper limit of reference range or over
  7. Previous radiation therapy to bones
  8. Hypercalcemia
  9. Primary bone malignancy or metastatic bone malignancy
  10. Allergy to teriparatide
  11. Pregnant women
  12. Previous therapy with teriparatide

Study & Design

Study Type
Interventional
Study Design
single assignment
Primary Outcome Measures
NameTimeMethod
-

Increase in trabecular bone score in lumbar spine bone mineral density after 2 years

Secondary Outcome Measures
NameTimeMethod
Trabecular volumetric bone mineral densities

Measured by 3D SHAPER

Cortical volumetric bone mineral densities

Measured by 3D SHAPER

Bone mineral densities

Measured by 3D SHAPER

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