Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Region Skane
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Bone density at the hip
Study Overview
Brief Summary
General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function).
The purpose of this study is to determine if surgery for pHPT, is appropriate for patients with moderate to mild hypercalcemia older than 65 years of age.
The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age, and with mild hypercalcemia, will increase bone density and hence decrease future risk for fragility fractures compared to patients with follow-up only.
Detailed Description
The majority of patients diagnosed and operated due to primary HPT in Scandinavia are older than 65 years of age. The vast majority of the patients have mild aberrations of serum calcium (< 1.50 mmol/l ionized calcium), and some patients may even be asymptomatic. The present trial is designed to clarify the indications for surgical treatment in this large subgroup of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 66 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary Hyperparathyroidism
- •No previous parathyroid surgery
- •Sporadic disease
Exclusion Criteria
- •Z-score of Bone density < -2.5 SD (regardless of site)
- •Serum level of ionized calcium > 1.50 mmol/L
- •Inability to understand given information or to comply with scheduled follow-up
- •Symptoms of hypercalcaemia for which specific medical treatment has been prescribed
Arms & Interventions
Follow-up
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only
Surgery
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery
Intervention: Parathyroid surgery (Procedure)
Outcomes
Primary Outcomes
Bone density at the hip
Time Frame: At two years
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
Secondary Outcomes
- Cardiac function(At two years)
- Blood lipids(At two years)
- Blood pressure (systolic and diastolic)(At two years)
- Atherosclerosis(At one two years)
- Renal function(At two years)
- Bone density at the lumbar spine(At two years)
- Cognitive function(At two years)
- Oral glucose tolerance(At two years)