Clinical trial NCT04085419: Osteoporosis in Primary Hyperparathyroidism
Official title: Management of Osteoporosis in Patients With Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Hyperparathyroidism
Osteoporosis
Keywords: zoledronic acid
denosumab
primary hyperparathyroidism
osteoporosis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (\>12 months after last menstrual period) with primary hyperparathyroidism and with osteoporosis on Dual Energy Xray Absorptiometry (DXA) (according to International Society for Clinical Densitometry (ISCD) - criteria) and/or osteoporotic fracture of the vertebra or hip

Exclusion Criteria:

* The patient is not able to give informed consent
* other classic complications of primary hyperparathyroidism (e.g. kidney stones, renal insufficiency)
* serum albumin-corrected calcium level \> 2.85 mmol/L (except when the patient is reluctant to undergo surgical treatment)
* osteoporosis treatment less than a year ago, less than two years ago in the case of oral bisphosphonate, less than three years ago in the case of parenteral bisphosphonate
* bilateral hip endoprosthesis
* additional causes for secondary osteoporosis (other than vitamin D deficiency) and pathological laboratory findings that are incompatible with the Summary of Product Characteristics (SmPC) of both medicines
* cancer, except if in stable remission of more than 5 years

Primary outcomes:
measure: Bone mineral density after one year of treatment
timeFrame: one year
measure: CTX after 3 months of treatment
timeFrame: 3 months
measure: Corrected calcium after 3 months of treatment
timeFrame: 3 months
measure: Bone mineral density after two years of treatment
timeFrame: two years
measure: CTX after 12 months of treatment
timeFrame: one year
measure: CTX after 24 months of treatment
timeFrame: two years
measure: PINP after 3 months of treatment
timeFrame: 3 months
measure: PINP after 12 months of treatment
timeFrame: one year
measure: PINP after 24 months of treatment
timeFrame: two years
measure: Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
timeFrame: 3 months
measure: Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
timeFrame: one year
measure: Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
timeFrame: two years
measure: Corrected calcium after 12 months of treatment
timeFrame: one year
measure: Corrected calcium after 24 months of treatment
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Endocrinology Department
Study officials:
affiliation: UMC Ljubljana
name: Tomaz Kocjan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: