Actively Recruiting
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
Led by Ditte Hansen · Updated on 2024-04-23
48
Participants Needed
4
Research Sites
298 weeks
Total Duration
On this page
Sponsors
D
Ditte Hansen
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for treatment of adynamic bone disorder in patients with chronic kidney disease.
CONDITIONS
Official Title
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years
- Chronic kidney disease stage 4-5D with eGFR 6429 ml/min according to KDIGO definition
- DXA scan with T-score or Z-score 652 at total hip, femoral neck, or lumbar spine in at least 2 vertebrae (or T-score/Z-score 651 for patients on oral prednisolone 5 mg/day for 6 months)
- History of fragility fracture (vertebral, hip, forearm, upper arm, ankle) confirmed by vertebral fracture assessment or X-ray
- Expected adynamic bone disorder based on bone specific alkaline phosphatase 6421 bcg/l or biopsy-verified low bone turnover
You will not qualify if you...
- Sustained hypercalcemia with ionized calcium >1.35 mmol/l
- Fracture within the last 6 months (patients may be rescreened after 6 months)
- Previous calciphylaxis
- Untreated or inadequately treated thyroid disorders
- Treatment with digoxin
- Paget's disease or other metabolic bone disorders
- Use of antiresorptive or bone anabolic medication in the last 24 months (bisphosphonates in last 12 months)
- Current or past malignant disease except skin basal or planocellular carcinoma
- Previous radiation therapy to the skeleton
- Kidney transplantation within the last 12 months
- 25 hydroxyvitamin D2 and D3 levels below 50 nmol/l (patients may be rescreened after correction)
- Inability to administer teriparatide
- Reduced liver function (ALAT >3x upper limit or bilirubin >2x upper limit)
- Pregnancy, lactation, or fertile women not using safe contraception
- Hypersensitivity to teriparatide or its excipients
- Inability to provide informed consent
- Medical conditions or treatments interfering with study assessments
- Drug or alcohol abuse
- Inability to participate based on investigator judgment
- For bone biopsy participants: hypersensitivity to tetracyclines, use of anticoagulants that cannot be paused, bleeding disorders
- For pulse wave measurement participants: atrial fibrillation or aortic stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820
Not Yet Recruiting
3
Herlev and Gentofte Hospital, Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
4
Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
Research Team
S
Sabina C Hauge, MD
CONTACT
D
Ditte Hansen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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