The efficacy and safety of teriparatide in advanced chronic kidney disease

JRCT ID: jRCTs041240136

Registered date:02/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoporosis, osteopenia
• Date of first enrollment: 02/12/2024
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Teriparatide 28.2 microg subcutaneous injection twice a year for two years

Outcome(s)

• Primary Outcome: Increase in trabecular bone score in lumbar spine bone mineral density after 2 years
• Secondary Outcome: Bone mineral densities, trabecular volumetric bone mineral densities and cortical volumetric bone mineral densities measured by 3D SHAPER, trabecular bone score after 1 year, and bone mineral markers such as calcium, phosphate, PTH, bone specific alkaline phosphatase, tartrate-resistant acid phosphatase-5b

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hamano Takayuki