Osteoporosis in Primary Hyperparathyroidism

Osteoporosis Clinical Trial

Official title:

Management of Osteoporosis in Patients With Primary Hyperparathyroidism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04085419
• Other study ID #: 11111
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 8, 2019
• Est. completion date: May 2023

Study information

• Verified date: November 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Osteoporosis
• Primary Hyperparathyroidism

Intervention

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

Locations

Country	Name	City	State
Slovenia	Endocrinology Department	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

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