Skip to content

Efficacy and side effects of denosumab for stage 3b-4 chronic kidney disease patients with osteoporosis: An open-label, prospective pilot clinical study

Efficacy and side effects of denosumab for stage 3b-4 chronic kidney disease patients with osteoporosis: An open-label, prospective pilot clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008213
Enrollment
40
Registered
2023-02-21
Start date
2020-06-01
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A total of 27 female patients with CKD stage 3b-4 and osteoporosis were enrolled. Twenty patients received denosumab plus calcium carbonate and vitamin D, and 7 control patients received calciu

Sponsors

Eulji University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal women aged 20 years or older with a Stage 3b-4 CKD (eGFR between 15 and 44 ml/min), and diagnosed with osteoporosis by DXA BMD T score =–2.5 (mean values over at least two parts of the lumbar spines, femur neck or total hip) or at least one vertebral fracture or femur fracture in DXA and whose PTH, Ca, and P levels are maintained within the reference range in the baseline were included

Exclusion criteria

Exclusion criteria: The exclusion criteria was a bone disease with endocrine diseases, rheumatoid arthritis, drugs affecting bone metabolism, a severe hyperparathyroidism (intact PTH > 500 pg/ml), uncontrolled hyperphosphatemia, previous osteoporosis treatment within 6 months, and dialysis treatment.

Design outcomes

Primary

MeasureTime frame
BMD, bone turnover markers, homocysteine and coronary calcium score were measured at baseline and after 1 year.

Secondary

MeasureTime frame
Total calcium, ionized calcium and PTH levels

Countries

Korea, Republic of

Contacts

Public ContactJin Taek Kim

Eulji University Medical Center

bessy@hanmail.net+82-2-970-8619

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026