Osteoporosis in Primary Hyperparathyroidism

Study Overview
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Brief Summary
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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.

Official Title
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Management of Osteoporosis in Patients With Primary Hyperparathyroidism

Conditions
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Primary Hyperparathyroidism, Osteoporosis

Intervention / Treatment
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* Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]
* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: denosumab<br>denosumab 60 mg subcutaneously every 6 months | Drug: Denosumab 60 MG/ML Prefilled Syringe [Prolia]<br>* denosumab 60 mg subcutaneously every 6 months<br>* Other names: Xgeva;|
| Active Comparator: zoledronic acid<br>zoledronic acid 5 mg intravenously once a year | Drug: Zoledronic Acid<br>* zoledronic acid 5 mg intravenously once a year<br>* Other names: Aclasta;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zoledronic acid, denosumab, primary hyperparathyroidism, osteoporosis