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

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.

Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism