RecruitingNot ApplicableNCT07171216

The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density

The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density (Biskjoldbruskkirtelhormon og knogletæthed Hos Patienter Med Kronisk Nyresygdom)


Sponsor

Herlev Hospital

Enrollment

70 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The prevalence of chronic kidney disease (CKD) in the adult population is estimated to 10%. CKD increases risk of bone fractures, cardiovascular disease and death. The main role of parathyroid hormone (PTH) is to regulate mineral metabolism, including the calcium and phosphate homeostasis. PTH increases as the kidney function declines, and at end stage kidney disease almost all patients have disturbances in the mineral metabolism. Decreasing bone mineral density is associated with risk of fracture, both in background population and in patients with CKD. For decades, treatment with activated vitamin D, phosphate binders, and calcium supplements has been used for patients with chronic kidney disease and elevated parathyroid hormone, but treatment targets have varied greatly over the years, reflecting the lack of randomized clinical trials with clinical important end points. The purpose of The REPAIR-CKD trial is to determine if treatment of hyperparathyroidism improves the bone mineral density in patients with chronic kidney disease. During this trial it will also be evaluated if it is feasible to obtain a difference in PTH levels when targeting two different levels of PTH. Further this trial will explore if a difference in PTH influences on arterial stiffness, muscle mass, muscle function, bone histology and health related quality of life.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether controlling parathyroid hormone (PTH) levels — a hormone that affects calcium and bone — helps preserve bone density in people with advanced chronic kidney disease (CKD) who have not yet started dialysis. **You may be eligible if...** - You are 50 years or older - You have advanced chronic kidney disease (stage 4 or 5, not on dialysis) - Your parathyroid hormone levels are elevated, or you are already being treated for this with vitamin D or cinacalcet - You are able to provide written consent **You may NOT be eligible if...** - You have had a kidney transplant - You are currently taking osteoporosis medications such as denosumab or bisphosphonates Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTreat to target

Participants will receive treatment from a "toolbox" depending on the situation to reach the PTH target. Available medication is mirroring what is used in the outpatient clinic setting already (native vitamin D, activated vitamin D, phosphate binders, calcimetics).


Locations(1)

Department of Nephrology, outpatient clinic, Herlev Hospital

Herlev, Capital Region, Denmark

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NCT07171216


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