Transiliac bone biopsy. Complications and diagnostic value.
S D Rao, V Matkovic, H Duncan
https://pubmed.ncbi.nlm.nih.gov/7287505Actively Recruiting
Phase Not Applicable
Age: 50Years +
All Genders
ID07171216
The Effect of Regulation of Parathyroid Hormone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density
Led by Herlev Hospital · Updated on 2026-01-06
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic kidney disease (CKD) affects about 10% of adults and raises the risk of bone fractures, heart disease, and death. This trial studies how controlling parathyroid hormone (PTH), which regulates minerals like calcium and phosphate and rises as kidney function declines, might improve bone health. The study aims to see if targeting different PTH levels affects bone mineral density (BMD) and also explores impacts on artery stiffness, muscle health, bone structure, and quality of life in CKD patients. Participants are randomly assigned to two groups with different PTH targets. One group will receive treatment to lower PTH as soon as it rises above the normal range using medicines like activated vitamin D, phosphate binders, native vitamin D, and calcimetics. The other group will only start treatment if PTH rises above five times the normal limit. Treatments reflect standard care options used in outpatient clinics. During the 18-month study, researchers will measure changes in bone mineral density, artery stiffness, muscle mass and strength, physical function tests, bone histology via biopsy, quality of life, and spinal fractures. PTH levels will be monitored regularly. This study involves outpatient visits for assessments, scans, blood tests, and biopsies to evaluate how different PTH targets affect health outcomes in CKD.
CONDITIONS
Brief Title
The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density
Who Can Participate
Age: 50Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 50 years of age or older at screening
- Chronic kidney disease stage G4 or G5 non-dialysis with eGFR below 30 mL/min/1.73m2
- Plasma parathyroid hormone (PTH) above the upper normal limit (> 8.5 µmol/L) and/or currently treated with active vitamin D or calcimetics
- Ability to provide written informed consent
You will not qualify if you...
- History of kidney transplantation
- Current treatment with specific anti-osteoporosis medications such as denosumab or bisphosphonates due to their strong effect on calcium, phosphate, and bone density
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 18 months
Participants receive treatment to manage parathyroid hormone (PTH) levels using medications such as activated vitamin D, phosphate binders, native vitamin D, and calcimetics according to their assigned target group.
Regular visits approximately every 3 to 6 months for PTH monitoring and treatment adjustments
Follow-up
Duration - Up to 18 months from baseline
Participants are monitored to assess changes in bone mineral density, arterial stiffness, muscle mass, muscle strength, and quality of life after treatment.
Visits at baseline and final follow-up at 18 months
Trial Site Locations
Total: 1 location
1
Department of Nephrology, outpatient clinic, Herlev Hospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
Loading map...
Research Team
F
Freja S Hassager, Medical doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Comparison of effective dose to children and adults from dual X-ray absorptiometry examinations.
Glen M Blake, Marium Naeem, Maria Boutros
https://pubmed.ncbi.nlm.nih.gov/16376161Radiation exposure in bone mineral density assessment.
C F Njeh, T Fuerst, D Hans...
https://pubmed.ncbi.nlm.nih.gov/10028639Reproducibility of pulse-wave analysis and pulse-wave velocity determination in chronic kidney disease.
Marie Frimodt-Møller, Arne Høj Nielsen, Anne-Lise Kamper...
https://pubmed.ncbi.nlm.nih.gov/17989106Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.
Kenneth G Saag, Jeffrey Petersen, Maria Luisa Brandi...
https://pubmed.ncbi.nlm.nih.gov/28892457Two-year cortical and trabecular bone loss in CKD-5D: biochemical and clinical predictors.
H H Malluche, M-C Monier-Faugere, G Blomquist...
https://pubmed.ncbi.nlm.nih.gov/28993865Kidney function and bone mineral density in chronic kidney disease patients.
Dong Hoon Kang, Cheol Ho Park, Hyung Woo Kim...
https://pubmed.ncbi.nlm.nih.gov/40034486KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD).
Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group
https://pubmed.ncbi.nlm.nih.gov/19644521KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD).
Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group
https://pubmed.ncbi.nlm.nih.gov/30675420Effect of Oral Alfacalcidol on Clinical Outcomes in Patients Without Secondary Hyperparathyroidism Receiving Maintenance Hemodialysis: The J-DAVID Randomized Clinical Trial.
J-DAVID Investigators, Tetsuo Shoji, Masaaki Inaba...
https://pubmed.ncbi.nlm.nih.gov/30535217