Osteoporosis in Primary Hyperparathyroidism

Phase 4

• Conditions: Primary Hyperparathyroidism; Osteoporosis
• Interventions: Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]; Drug: Zoledronic Acid

• Registration Number: NCT04085419
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-08
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-07
• Study First Posted: 2019-09-11
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
denosumab	Denosumab 60 MG/ML Prefilled Syringe [Prolia]	denosumab 60 mg subcutaneously every 6 months
zoledronic acid	Zoledronic Acid	zoledronic acid 5 mg intravenously once a year

Primary Outcome Measures

Name	Time	Method
Bone mineral density after one year of treatment	one year	Dual-energy X-ray absorptiometry (DXA)
PINP after 12 months of treatment	one year	Unit of Measure: µg/L
PINP after 24 months of treatment	two years	Unit of Measure: µg/L
CTX after 12 months of treatment	one year	Unit of Measure: pmol/L
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment	one year	Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment	two years	Unit of Measure: µg/L
Corrected calcium after 3 months of treatment	3 months	Unit of Measure: mmol/L
PINP after 3 months of treatment	3 months	Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment	3 months	Unit of Measure: µg/L
Corrected calcium after 24 months of treatment	two years	Unit of Measure: mmol/L
CTX after 3 months of treatment	3 months	Unit of Measure: pmol/L
Bone mineral density after two years of treatment	two years	Dual-energy X-ray absorptiometry (DXA)
CTX after 24 months of treatment	two years	Unit of Measure: pmol/L
Corrected calcium after 12 months of treatment	one year	Unit of Measure: mmol/L

Trial Locations

Locations (1)

Endocrinology Department; 🇸🇮 Ljubljana, Slovenia