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Paul A Harris, Robert Taylor, Brenda L Minor...
https://pubmed.ncbi.nlm.nih.gov/31078660Actively Recruiting
Phase 4
Age: 50Years +
All Genders
ID06859580
Bisphosphonate vs. Placebo Prior to Parathyroidectomy in Primary Hyperparathyroidisme: A Randomized, Double-blinded Placebo-controlled Trial
Led by University of Aarhus · Updated on 2025-03-25
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a single infusion of zoledronic acid (ZOL) compared to placebo in patients with primary hyperparathyroidism (PHPT) undergoing parathyroidectomy (PTX). PHPT is an endocrine disorder characterized by high calcium levels, reduced bone density, increased fracture risk, kidney calcifications, and cardiovascular problems. The study aims to determine if ZOL given before surgery influences bone health, cardiovascular measures, and kidney function one year after PTX. Participants will be randomly assigned to receive either a 4 mg intravenous infusion of ZOL or a placebo saline solution 2 to 4 weeks before their PTX surgery. The trial is double-blinded, so neither patients nor researchers know who receives which treatment. All patients will be advised to take daily calcium and vitamin D supplements after surgery. The study includes extensive imaging such as DXA, high-resolution CT scans, cardiac CT, and ultrasounds, along with blood and urine tests to assess bone density, bone microarchitecture, biochemical markers, coronary artery calcium score, arterial stiffness, and renal calcifications. Participants, who are postmenopausal women or men over 50 with PHPT and low bone density, will be assessed at baseline and again one year after surgery. They will complete questionnaires on symptoms and quality of life. Safety monitoring includes tracking side effects, blood tests, and scans. The primary outcome is the change in bone mineral density at the lumbar spine one year after PTX. Secondary outcomes include bone density changes at other skeletal sites, bone turnover markers, cardiovascular measures, and kidney calcifications. The study duration for participants is approximately one year after surgery.
CONDITIONS
Brief Title
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Who Can Participate
Age: 50Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Postmenopausal females or males over 50 years
- Diagnosed with hyperparathyroid hypercalcemia due to sporadic primary hyperparathyroidism referred to parathyroidectomy
- Areal bone mineral density T-score of -1 or lower at total hip, femoral neck, or lumbar spine
- 25-hydroxyvitamin D level of 50 nmol/l or higher before randomization
- Willingness to undergo parathyroidectomy
You will not qualify if you...
- Known or suspected familial causes of hyperparathyroidism (e.g., MEN1 or MEN2)
- Estimated glomerular filtration rate less than 35 ml/min
- Known allergy to bisphosphonates
- Planned or recent major dental procedures within the last 3 months (e.g., jaw surgery or tooth extraction)
- Chronic or acute disorders affecting bone metabolism (e.g., rheumatoid arthritis, inflammatory bowel disease, cancer)
- Prior use of medications affecting bone metabolism within specified timeframes (e.g., lithium, glucocorticoids within last year, antiresorptive or bone anabolic treatments within last 3 years)
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)
Run-in Period
Duration - 2 to 4 weeks
Participants receive a single intravenous infusion of either zoledronic acid or placebo approximately 2 to 4 weeks prior to parathyroidectomy.
1 infusion visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 week or until discharge
Participants undergo parathyroidectomy surgery to treat primary hyperparathyroidism.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants have follow-up assessments to monitor recovery and effects of the treatment, including bone density scans, blood and urine tests, cardiac CT scans, tonometry, and questionnaires.
1 follow-up visit at 12 months post-surgery; additional visits for blood tests and assessments may occur depending on participant group
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Central Region of Denmark, Denmark, 8200
Actively Recruiting
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Research Team
A
Anne Louise Vandsø Svenningsen, MD
H
Henriette Ejlsmark Svensson, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.
Paul A Harris, Robert Taylor, Robert Thielke...
https://pubmed.ncbi.nlm.nih.gov/18929686Sporadic primary hyperparathyroidism and stone disease: a comprehensive metabolic evaluation before and after parathyroidectomy.
Giovanni S Marchini, Kauy V M Faria, Fábio C M Torricelli...
https://pubmed.ncbi.nlm.nih.gov/29124877Biochemical characterization of primary hyperparathyroidism with and without kidney stones.
Clarita V Odvina, Khashayar Sakhaee, Howard J Heller...
https://pubmed.ncbi.nlm.nih.gov/17476495Primary hyperparathyroidism: renal calcium excretion in patients with and without renal stone sisease before and after parathyroidectomy.
Vibe G Frøkjaer, Charlotte L Mollerup
https://pubmed.ncbi.nlm.nih.gov/12098039Risk factors associated to kidney stones in primary hyperparathyroidism.
S Corbetta, A Baccarelli, A Aroldi...
https://pubmed.ncbi.nlm.nih.gov/15887857The effect of parathyroidectomy on the recurrence of nephrolithiasis.
T F Deaconson, S D Wilson, J Lemann
https://pubmed.ncbi.nlm.nih.gov/3686354Risk of renal stone events in primary hyperparathyroidism before and after parathyroid surgery: controlled retrospective follow up study.
Charlotte L Mollerup, Peter Vestergaard, Vibe Gedsø Frøkjaer...
https://pubmed.ncbi.nlm.nih.gov/12376441Renal stones and primary hyperparathyroidism: natural history of renal stone disease after successful parathyroidectomy.
C L Mollerup, H Lindewald
https://pubmed.ncbi.nlm.nih.gov/9880427Oral calcium supplementation associated with decreased likelihood of nephrolithiasis prior to surgery for hyperparathyroidism.
Matthew R Cooperberg, Quan-Yang Duh, G Bennett Stackhouse...
https://pubmed.ncbi.nlm.nih.gov/18036056