Regulating parathyroid hormone to improve bone mineral density in people with advanced chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, interventional 'treat-to-target' trial enrolls adults aged 50 or older with CKD G4–G5 non-dialysis and elevated PTH to test whether suppressing PTH improves bone mineral density. Participants will receive activated vitamin D (alphacalcidol) or calcimimetic therapy (e.g., cinacalcet) as needed to reach predefined PTH targets while avoiding specific anti-osteoporosis medications. The primary outcome is change in bone mineral density, with secondary measures including fracture-related events and biochemical markers of mineral metabolism. Patients with prior kidney transplant or current treatment with bisphosphonates or denosumab are excluded, and follow-up visits are conducted at the Herlev Hospital nephrology outpatient clinic.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥50 years of age at screening
2. CKD G4-5nonD (eGFR \< 30 mL/min/1.73m2) based on local laboratory assessment of serum creatinine and eGFR estimated by the CKD-EPI formula)
3. Plasma PTH \> upper normal limit of local laboratory reference range (\> 8,5µmol/L) and/or treated with active vitamin D (Alphacalcidol) or calcimetics (Cinacalcet) initially
4. Written informed consent

Exclusion Criteria:

1. Patients who have received a kidney transplant
2. Patients receiving treatment with specific anti-osteoporosis medication (denosumab/bisphosphonates) (because of the profound effect on calcium/phosphate fluxes and BMD)

Where it's running

• Department of Nephrology, outpatient clinic, Herlev Hospital
  Herlev, Capital Region, Denmark Recruiting

Study contacts

• Study coordinator: Freja S Hassager, Medical doctor
• Email: freja.staehr.hassager.01@regionh.dk
• Phone: 0045+22554707

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.