What is zoledronic acid studying for primary hyperparathyroidism?

Zoledronic acid is being studied to see if a single infusion before parathyroid surgery improves bone health, cardiovascular function, and kidney outcomes in patients with primary hyperparathyroidism. The trial aims to understand if this treatment affects bone recovery and other health measures one year after surgery.

Who may be eligible for this primary hyperparathyroidism clinical trial?

Adults 50 years or older with a diagnosis of primary hyperparathyroidism and low bone mineral density may be eligible. Both men and postmenopausal women can participate. Important factors include willingness to have parathyroid surgery and no recent major dental procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this primary hyperparathyroidism clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 50Years +

All Genders

ID06859580

Study of Zoledronic Acid Compared to Placebo Before Parathyroid Surgery in Patients Over 50 with Primary Hyperparathyroidism and Low Bone Density

Led by University of Aarhus · Updated on 2025-03-25

140

Participants Needed

Research Sites

N/A

Total Duration

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)

Research Team

Anne Louise Vandsø Svenningsen, MD

Henriette Ejlsmark Svensson, MD, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here