Regulating parathyroid hormone to improve bone mineral density in people with advanced chronic kidney disease
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)
This study will try lowering high parathyroid hormone with activated vitamin D or calcimimetics to see if bone mineral density improves in people over 50 with advanced chronic kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Herlev, Capital Region) |
| Trial ID | NCT07171216 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults ≥50 years with CKD G4–G5 (eGFR <30 mL/min/1.73 m2) who have elevated PTH or are already on active vitamin D or calcimimetic therapy and can give informed consent.
Not a fit: People with a prior kidney transplant or those already taking anti-osteoporosis drugs like bisphosphonates or denosumab are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could reduce bone loss and lower fracture risk in older patients with advanced CKD.
How similar studies have performed: Longstanding observational data and clinical use of activated vitamin D and calcimimetics support improved mineral metabolism, but randomized trials with BMD and fracture endpoints remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Herlev, Capital Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.