Status:
UNKNOWN
Osteoporosis in Primary Hyperparathyroidism
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Primary Hyperparathyroidism
Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04085419
Start Date
May 8 2019
End Date
May 1 2023
Last Update
November 4 2022
Active Locations (1)
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1
Endocrinology Department
Ljubljana, Slovenia, 1000