Clinical trial NCT01087619: Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up
Official title: Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Hyperparathyroidism
Keywords: Hyperparathyroidism, primary
Aged 66 years or older
Mild hypercalcaemia
Surgical Procedures, Elective
Indication
Osteoporosis
Cognitive function
Atherosclerosis
Follow-up
Randomized trial
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 115
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone density at the hip
timeFrame: At two years
Secondary outcomes:
measure: Bone density at the lumbar spine
timeFrame: At two years
measure: Blood lipids
timeFrame: At two years
measure: Cardiac function
timeFrame: At two years
measure: Cognitive function
timeFrame: At two years
measure: Atherosclerosis
timeFrame: At one two years
measure: Oral glucose tolerance
timeFrame: At two years
measure: Blood pressure (systolic and diastolic)
timeFrame: At two years
measure: Renal function
timeFrame: At two years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital, Department of Surgery, Lund
Study officials:
affiliation: Skåne University Hospital, Department of Surgery, Lund
name: Anders OJ Bergenfelz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: